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Trial registered on ANZCTR
Registration number
ACTRN12620000928910
Ethics application status
Approved
Date submitted
16/06/2020
Date registered
17/09/2020
Date last updated
5/11/2021
Date data sharing statement initially provided
17/09/2020
Date results information initially provided
17/09/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
A practice based trial of a combination of nutritional interventions: probiotics, glutamine and fish oils in patients experiencing psychological distress.
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Scientific title
Investigating the effect of a novel nutritional intervention (probiotics, glutamine and fish-oil) on mild-moderate psychological distress in adults: a concurrent multiple baseline design
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Secondary ID [1]
301248
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psychological distress
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Mild digestive discomfort
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Condition category
Condition code
Alternative and Complementary Medicine
315645
315645
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0
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Other alternative and complementary medicine
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Mental Health
316314
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention consisted of 3 nutritionally based supplements or their matched placebos. In this multiple baseline study design participants were randomised into 3 groups based on the duration of their exposure to the verum intervention. Group 1 took 6 weeks of placebos followed by 12 weeks of verum supplements, Group 2 had 8 weeks of placebos followed by 10 weeks of verum supplements and group 3 took placebo for 12 weeks and then 6 weeks of verum supplements. Each participant took two doses of each supplement/placebo supplement each day of the trial. The doseage form and contents of the verum supplements are detailed below per dose.
a) Metagenics Ultra Flora Intensive Care (ARTG 286746) 600mg maroon (00 size Vcap with cream coloured powder) clear capsule for oral consumption containing Lactobacillus rhamnosus (LGG®) (10 x 109CFU), Saccharomyces cerevisiae (boulardii) (7.5 x 109 CFU) and Bifidobacterium animalis ssp lactis (BB-12®) (5 x 109 CFU).
Participants swallowed one capsule of this probiotic supplement morning and evening.
b) Metagenics Glutagenics (ARTG 213315) Powder for oral consumption after dissolving in water.
Each 4.33g dose contains: Aloe vera 3.25mg/g (equiv. fresh herb 649.35mg/g); Boswellia serrata 19.48mg/g (equiv. fresh herb 194.8mg/g); Cholecalciferol 1.6233mcg/g; Glutamine 285.71mg/g; Larix arabinogalactan 259.74mg/g; Retinol palmitate 178.57mcg/g; Zinc amino acid chelate 9.74mg/g.
Participants took one dose: 7.7g (two scoops - scooop included) of this oral powder supplement in 200ml water morning and evening.
All practitioner researchers were qualified naturopathic practitioners, apart from one who was a qualified nutritionist. It was beyond the scope of this practitioner reseracher to prescribe herbal medicines so the two participants that she monitored were given the same total daily dose of glutamine (571 mg) as used in the above supplement, encapsulated into 3 opaque capsules which were taken twice a day, by these two participants or a matched placebo.
c) Metagenics Metapure EPA/DHA oral liquid (ARTG 227557). Each ml
contains: concentrated fish Omega-3 triglycerides 952.38 mg/mL. Participants took 2.1ml twice daily with meals (breakfast and dinner).
Supplements were returned at each study clinic and the quantity remaining was rmeasured and recorded by the practitioner reserachers as a) the number of capsules, b) the weight of the powder and c) the volume of the liquid.
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Intervention code [1]
317649
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Treatment: Drugs
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Intervention code [2]
317650
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Treatment: Other
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Comparator / control treatment
Placebo a: (matching the probiotic) 400mg maroon (00 size Vcap containing off-white coloured powder) clear capsule containing microcrystalline cellulose (MCC).
Placebo b: (matching the powdered glutamine based nutritional formula) powder for oral liquid consisting of maize maltodextrin IT 19 AGGLOM 4.497g, Malic acid 0.3g, Flavor lemon lime 0.1g, silicon dioxide (Syloid 244) 0.039g, Steviol glycosides, Reb A 0.034g, lemon Encapsulate 0.03g.
Placebo b for the participants of the practitioner researcher who could not prescribe herbal medicine: The placebo contained only maize maltodextrin.
Placebo c: (matching the fish oil) oral liquid consisting of safflower, Steviol glycosides, Reb A 0.034g, lemon Encapsulate 0.03g, 10% fish oil as a masking agent (positive placebo)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Kessler-10 scale of psychological distress (K-10); a 10 item validated and reliable scale of the risk of severe mental disorder.
Change in total score as estimate of change in risk of mental disorder.
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Assessment method [1]
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Timepoint [1]
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Seven time points; the initial screening clinic (week -2) and 6 subsequent clinics (week 0, week 4, week 8, week 12, week 16 and week 18).
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Secondary outcome [1]
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Percieved Stress Scale-10 (PSS-10); a 10-item self-reported measure of perceived stress.
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Assessment method [1]
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Timepoint [1]
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Baseline clinic (week 0) and 5 subsequent study clinics (week 4, week 8, week 12, week 16 and week 18).
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Secondary outcome [2]
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A 25 item Abbreviated Profile of Mood States (POMS) Short Form. This was a measure of total mood disturbance.
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Assessment method [2]
383245
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Timepoint [2]
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Weekly from the baseline clinic at week 0 to the final clinic in week 18: 18 timepoints
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Secondary outcome [3]
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Gastrointestinal Symptom Rating Scale (GSRS): 15 items evaluating common symptoms of gastrointestinal disorders using a four point response scale from no discomfort to sufficent discomfort to impair social activities.
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Assessment method [3]
383246
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Timepoint [3]
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Six timepoints, at the Baseline clinic (week 0) and 5 subsequent study clinics (week 4, week 8, week 12, week 16 and week 18).
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Secondary outcome [4]
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Change in gut microflora was measured using Complete Digestive Stool Analysis (CDSA) to assess numbers of colony forming units (CFU) of Bifidobacterium spp. at baseline and post intervention.
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Assessment method [4]
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Timepoint [4]
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Two timepoints: week 0 and week 18 study clinic.
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Secondary outcome [5]
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C-reactive protein (CRP) mg/L a biomarker for inflammation. Change in level at baseline compared with post intervention measured by serum assay.
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Assessment method [5]
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Timepoint [5]
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Two timepoints: week 0 and week 18
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Secondary outcome [6]
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'Change in gut microflora was measured using Complete Digestive Stool Analysis (CDSA) to assess numbers of colony forming units (CFU) of Lactobacillus spp. at baseline and post intervention'
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Assessment method [6]
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Timepoint [6]
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Two time points: week 0 and Week 18.
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Secondary outcome [7]
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Change in gut microflora was measured using Complete Digestive Stool Analysis (CDSA) to assess numbers of colony forming units (CFU) of Escherichia spp. (E. coli) at baseline and post intervention.
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Assessment method [7]
384782
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Timepoint [7]
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Two time points: week 0 and week 18.
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Secondary outcome [8]
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Change in gut microflora was measured using Complete Digestive Stool Analysis (CDSA) to assess numbers of colony forming units (CFU) of Enterococcus spp. at baseline and post intervention
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Assessment method [8]
384783
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Timepoint [8]
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Two time points: week 0 and week 18
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Secondary outcome [9]
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Change in GIT function was measured using Complete Digestive Stool Analysis (CDSA) to assess levels of faecal calprotectin ug/g.
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Assessment method [9]
384784
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Timepoint [9]
384784
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At two timepoints: week 0 and week 18
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Secondary outcome [10]
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Change in GIT function was measured using Complete Digestive Stool Analysis (CDSA) to assess levels of faecal zonulin ng/g.
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Assessment method [10]
384785
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Timepoint [10]
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At two timepoints: week 0 and week 18.
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Secondary outcome [11]
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Change in GIT function was measured using Complete Digestive Stool Analysis (CDSA) to assess levels short chain fatty acids in umol/g.
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Assessment method [11]
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Timepoint [11]
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Two timepoints: week 0 and week 18.
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Secondary outcome [12]
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Patient perspectives on patient outcomes. This will be assessed by a one-on-one interview between the patient and the practitioner.
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Assessment method [12]
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Timepoint [12]
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One-off interview within 9 months after Week 18. This timeframe is to align with individual participant feedback on all outcome measures, including pathology and stool tests results. In this interview the practitioner researcher will discuss and interpret individual results. Patients will then reflect on their experience in the trial. This timeframe will also accommodate return to routine clinical practice where appointments are negotiated between patients and practitioners as needed.
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Eligibility
Key inclusion criteria
Individuals with:
- a score of greater than or equal to 16 and less than 30 on the K-10 scale
- symptoms of mild gut dysfunction (e.g. abdominal cramps or sharp pains, recurrent diarrhoea or constipation, excessive wind, abdominal bloating)
- agree to comply with the study protocols
- willing to have blood taken on two occasions during the study
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Individuals
- taking immunosuppressive medication
- taking Warfarin or other anticoagulant medication
- who have major surgery within the last 6 months
- diagnosed with chronic mental health conditions and taking prescribed medication for same (unless their condition has been stable for a minimum of 12 months)
- with diabetes
- with BMI greater than or equal to 35
- unexplained weight loss
- Females who are lactating, pregnant or planning to become pregnant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, allocation concealment involved contacting the holder of the allocation schedule who was at the central administration site and not otherwise involved with the trial.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sponsor agreed to take on the random sequence generation using a computer-generated sequence. Participants, practitioner reseracher and the N-of-1 trials unit were all blinded to the sequence which was held by an acedemic at the central administration site and not otherwise involved with the trial.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
An N-of-1 trial with multiple base line design, such that participants in all groups started the intervention phase of the trial taking placebo supplements. Each group subsequently moved to the verum supplements and remained on these till the end of the study. This design was employed as hypothesiesed alterations to the microbiome could not be reliably and ethically 'washed out' , as required in a cross-over design.
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary method of analysis will employ systematic visual graphing of the outcome measures over the placebo/verum conditions, as recommended by the CONSORT collaboration, extension for N-of-1 studies. Each trial will be analysed separately by the researchers. The results of all the trials will be aggregated to form an exploratory analysis using mixed modeling techniques.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/07/2019
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Date of last participant enrolment
Anticipated
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Actual
1/08/2019
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Date of last data collection
Anticipated
25/09/2020
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Actual
31/12/2020
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Sample size
Target
10
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment postcode(s) [1]
30364
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5171 - Mclaren Vale
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Recruitment postcode(s) [2]
30367
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2830 - Dubbo
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Recruitment postcode(s) [3]
30368
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2000 - Sydney
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Recruitment postcode(s) [4]
30370
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4000 - Brisbane
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Recruitment postcode(s) [5]
30554
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3000 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian Traditional Medicine Society
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Address [1]
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Suite 12/27 Bank St Meadowbank NSW 2114
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Southern Cross University
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Address
Military Road
East Lismore NSW 2480
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
306111
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Not applicable
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Address [1]
306111
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Not applicable
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Country [1]
306111
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Cross Univeristy, Human Reserach Ethics Commitee
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Ethics committee address [1]
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Military Road
East Lismore
NSW 2480
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/08/2018
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Approval date [1]
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20/11/2018
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Ethics approval number [1]
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ECN-18-192
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Summary
Brief summary
Mental health problems affect one in five Australians every year. Psychological distress may be a risk factor for more serious mental health conditions. Recent research on the microbiome of the gastrointestinal tract suggests a complex interaction between this community of bacteria and the health and mental well-being of the host. Lack of balance in the microbiome is often indicated by mild digestive discomfort.
This study investigates a combination of nutrients that have been found to benefit the gastrointestinal tract (glutamine), the microbiome (probiotics) and support healthy mood balance (fish oil) in 10 individuals who suffer mild digestive symptoms and psychological distress. This study aims to investigate the effects of this combination of nutrients on perceptions of psychological distress in these 10 specific individuals. The data from the placebo phase and the ‘active treatment’ phase will be compared for each individual participant and will also be combined to explore some preliminary more general findings that will help with the design of future studies in this area.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sandra Grace
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Address
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N-of-1 Clinical Trials Group
School of Health and Human Sciences
Southern Cross University
Military Rd
East Lismore
NSW 2480
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Country
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Australia
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Phone
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+61 2 6620 3646
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Sandra Grace
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Address
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N-of-1 Clinical Trials Group
School of Health and Human Sciences
Southern Cross University
Military Rd
East Lismore
NSW 2480
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Country
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Australia
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Phone
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+61 2 6620 3646
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Joanne Bradbury
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Address
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N-of-1 Clinical Trials Group
School of Health and Human Sciences
Southern Cross University
Southern Cross Drive
Bilinga QLD 4225
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Country
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Australia
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Phone
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+61 7 5589 3244
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Results: The data showed a general trend towards l...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A Novel Nutrient Intervention of Probiotics, Glutamine, and Fish Oil in Psychological Distress: A Concurrent Multiple Baseline Design.
2023
https://dx.doi.org/10.1089/jicm.2022.0820
N.B. These documents automatically identified may not have been verified by the study sponsor.
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