Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000116820
Ethics application status
Approved
Date submitted
26/11/2020
Date registered
5/02/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
5/02/2021
Date results provided
11/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of the herbal preparation, STW5-II, on gastrointestinal motility in healthy volunteers
Scientific title
The effects of the herbal preparation, STW5-II, on antropyloroduodenal motility in healthy volunteers
Secondary ID [1] 302576 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 319559 0
Condition category
Condition code
Oral and Gastrointestinal 317489 317489 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects.

Two study visits, separated by at least four days, are required. Participants will receive, in randomised, double-blind fashion, oral administration of either (i) 20 drops (1.1ml) of STW5-II or (ii) 20 drops (1.1ml) control solution (i.e. containing no active ingredients).
For both study visits, participants will fast for ~14 hrs overnight, and abstain from alcohol and vigorous exercise for 24 hrs prior to each visit. On each study day, participants will attend the Clinical Research Facility, Adelaide Medical School, Adelaide Health and Medical Sciences Building at 8:30am.

Upon arrival, the participant will be intubated with a custom-built manometric catheter (outer diameter: 4 mm; Dentsleeve International, Mui Scientific, Mississauga, Ontario, Canada) which will be inserted through an anaesthetised nostril and allowed to pass through the stomach and into the duodenum by peristalsis. The manometric catheter, consisting of 16 side-holes, spaced at 1.5 cm intervals, will measure antropyloroduodenal (APD) pressures (i.e. pressures in the antrum, pylorus and duodenum). Six side-holes (channels 1 - 6) will be positioned in the antrum, a 4.5 cm sleeve sensor (channel 7), with 2 channels present on the back of the sleeve (channels 8 and 9), positioned across the pylorus, and 7 channels in the duodenum (channels 10 - 16). The correct positioning of the catheter, so the sleeve sensor straddles the pylorus, will be maintained by continuous measurement of the transmucosal potential difference (TMPD) between the most distal antral channel (channel 6) and the most proximal duodenal channel (channel 10). All manometric channels will be perfused with degassed, distilled water, except for the two TMPD channels, which will be perfused with degassed 0.9 % saline, at 0.15 ml/min. Once the catheter is in the correct position, fasting motility will be monitored continuously, and immediately after the end of phase III activity of the fasting migrating motor complex (MMC), during a period of motor quiescence (phase I of the MMC) (t = -10 to 0 min), the participant will complete a VAS questionnaire to assess GI perceptions (fullness, nausea, bloating). These scales consist of a horizontal line, 100 mm long, on which the participant places a vertical mark across the line, indicating the strength of each symptom felt at that time, with 0 mm indicating that the symptom is not felt and 100 mm that the symptom is extremely strong. At t = 0 min, participants will ingest 100 ml of water with either (i) STW5-II or (ii) control solution (as stated previously). APD motility will then be monitored for 180 min. During the 180-min monitoring period, participants will complete VAS questionnaires every 15 min. At t = 180 min, the manometric catheter will be removed, and the participant offered a light lunch before being free to leave the laboratory.
Intervention code [1] 318940 0
Treatment: Other
Comparator / control treatment
20 drops (1.1 ml) Ethanolic liquid
Control group
Placebo

Outcomes
Primary outcome [1] 325796 0
Motility index of antral pressures.

Number and amplitude of antral pressure waves will be measured using a manometric catheter, connected to a computer-based system running commercially available software (MMS Database software, version 8.17; Solar GI).

The motility index is calculated with the following equation.
MI = In ([number of waves x X amplitude] + 1).
Timepoint [1] 325796 0
For each study visit, motility index will be calculated per 15 min segment of motility measurement between t = 0 min and t = 180 min.
Secondary outcome [1] 389212 0
Number and amplitude (mmHg) of antral pressure waves. This is a composite outcome.

Number and amplitude of antral pressure waves will be measured using a manometric catheter, connected to a computer-based system running commercially available software (MMS Database software, version 8.17; Solar GI).
Timepoint [1] 389212 0
For each study visit, number and amplitude (mmHg) of antral pressure waves will be measured per 15 min segment of motility measurement between t = 0 min and t = 180 min.
Secondary outcome [2] 389213 0
Number and amplitude (mmHg) of duodenal pressure waves. This is a composite outcome.

Number and amplitude of duodenal pressure waves will be measured using a manometric catheter, connected to a computer-based system running commercially available software (MMS Database software, version 8.17; Solar GI).
Timepoint [2] 389213 0
For each study visit, number and amplitude (mmHg) of duodenal pressure waves will be measured per 15 min segment of motility measurement between t = 0 min and t = 180 min.
Secondary outcome [3] 389214 0
Number and amplitude (mmHg) of isolated pyloric pressure waves (IPPWs). This is a composite outcome.

Number and amplitude of IPPWs will be measured using a manometric catheter, connected to a computer-based system running commercially available software (MMS Database software, version 8.17; Solar GI).
Timepoint [3] 389214 0
For each study visit, number and amplitude of IPPWs will be measured per 15 min segment of motility measurement between t = 0 min and t = 180 min.
Secondary outcome [4] 389215 0
Basal pyloric pressure.

Basal pyloric pressure will be measured using a manometric catheter, connected to a computer-based system running commercially available software (MMS Database software, version 8.17; Solar GI).
Timepoint [4] 389215 0
For each study visit, basal pyloric pressure will be calculated per 15 min segment of motility measurement between t = 0 min and t = 180 min.

Eligibility
Key inclusion criteria
Healthy, lean (BMI: 19-25 kg/m2) male and female volunteers will be included. Participants will be required to be weight-stable (ie <5% fluctuation) at study entry. Females will be required to be premenopausal and studied during the follicular phase of the menstrual cycle.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each participant will be questioned prior to the study to exclude:
- regular GI symptoms, as measured by the GI symptom score (score >1 for any component), or significant GI disease or surgery
- use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
- regular medication that cannot be discontinued during the study
- lactose intolerance/other food allergy, or allergy to any of the ingredients of STW5-II
- current gallbladder or pancreatic disease
- cardiovascular or respiratory diseases
- epilepsy
- any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
- high performance athletes
- current intake of > 2 standard drinks on > 5 days per week
- current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping)
- recreational drug use (e.g marijuana)
- current intake of any illicit substance
- vegetarians
- inability to tolerate oro/naso-gastric tube
- inability to comprehend study protocol
- in female participants, pregnancy, lactation or surgical sterilisation (a pregnancy test will be performed, using a urine sample, prior to each study day)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2021
Actual
11/02/2021
Date of last participant enrolment
Anticipated
15/04/2021
Actual
29/06/2021
Date of last data collection
Anticipated
30/04/2021
Actual
19/07/2021
Sample size
Target
18
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307008 0
Commercial sector/Industry
Name [1] 307008 0
Steigerwald Arzneimittelwerk GmbH
Country [1] 307008 0
Germany
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace,
Adelaide 5005,
South Australia
Country
Australia
Secondary sponsor category [1] 307576 0
Individual
Name [1] 307576 0
Professor Christine Feinle-Bisset
Address [1] 307576 0
Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George Street,
Adelaide 5005,
South Australia
Country [1] 307576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307140 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307140 0
Ethics committee country [1] 307140 0
Australia
Date submitted for ethics approval [1] 307140 0
Approval date [1] 307140 0
31/08/2020
Ethics approval number [1] 307140 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106174 0
Prof Christine Feinle-Bisset
Address 106174 0
University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005
South Australia
Country 106174 0
Australia
Phone 106174 0
+61 8 8313 6053
Fax 106174 0
Email 106174 0
[email protected]
Contact person for public queries
Name 106175 0
Christine Feinle-Bisset
Address 106175 0
University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005
South Australia
Country 106175 0
Australia
Phone 106175 0
+61 8 8313 6053
Fax 106175 0
Email 106175 0
[email protected]
Contact person for scientific queries
Name 106176 0
Christine Feinle-Bisset
Address 106176 0
University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building,
Cnr North Terrace and George St,
Adelaide 5005
South Australia
Country 106176 0
Australia
Phone 106176 0
+61 8 8313 6053
Fax 106176 0
Email 106176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with IP Agreement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.