None listed
Conditions
Brief summary
This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, vs placebo, to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Participants will attend two visits at which they will receive either STW5-II or placebo, and gastrointestinal motility will be measured for the following three hours. The hypothesis is that STW5-II will increase antral contractility compared with placebo.
Interventions
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 in
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.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
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)
Outcome results
None listed