None listed
Conditions
Brief summary
The aim of the study is to assess the tolerability and efficacy of a herbal powder preparation for gastrointestinal disturbances. Gastrointestinal problems in the upper and lower gastrointestinal tract can manifest as frequent reflux or irritable bowel symptoms. The Nutrition Care Gut Relief Formula contains a mixture of herbs and nutrients which have been shown to be beneficial for the gastrointestinal system. In this interventional pre-post single-arm dose-response study of 16 weeks duration we aim to investigate the tolerability and the effectiveness of the Nutrition Care Gut Relief Formula on gastrointestinal disturbances in Australian adults.
Interventions
Single-arm pre-post dose-response study of 16 weeks duration investigating the effect of the Nutrition-Care Gut-Relief-Formula on gastrointestinal disturbances in Australian adults. After a run-in-phase of 4 weeks of observation only, the intervention will comprise 5g powder in sachets per day of the Gut-Relief Formula for 4 weeks, followed by 10g powder in sachets per day of the Gut-Relief Formula for 2x4 weeks. The commercially available Gut-Relief Formula contains a mixture of 10 herbs and nu
Single-arm pre-post dose-response study of 16 weeks duration investigating the effect of the Nutrition-Care Gut-Relief-Formula on gastrointestinal disturbances in Australian adults. After a run-in-phase of 4 weeks of observation only, the intervention will comprise 5g powder in sachets per day of the Gut-Relief Formula for 4 weeks, followed by 10g powder in sachets per day of the Gut-Relief Formula for 2x4 weeks. The commercially available Gut-Relief Formula contains a mixture of 10 herbs and nutrients*, which have individually shown to relief gastrointestinal disturbances. Adherence will be assessed after 4, 8 and 12 weeks by count of remaining sachets of the investigational product * The Gut Relief Formula powder - to be dissolved in water - contains Curcuma, Glutamine, Quercetin, Glucosamin hydrochloride, Aloe vera, Ulmus rubra, Guar gum, Pectin, Peppermint oil, Sodium phosphate.
Sponsors
A/Prof Dr Karin Ried
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with moderate gastrointestinal disturbances (upper and/or lower gastrointestinal tract). Participants may experience one or multiple symptoms at least once a week for at least 3 months: Of the upper gastrointestinal tract: Suffering from Indigestion, Heartburn, Regurgitation, and/or Nausea at least once weekly for at least 3 months assessed by Short Form Leeds dyspepsia questionnaire and/or Of the lower gastrointestinal tract: IBS-like symptoms, assessed by the ROME IV criteria a. IBS with predominant constipation: Bristol stool type 1 & 2 (more than 25%), type 6 & 7 (< 25%) b. IBS with predominant diarrhea: Bristol stool type 1 & 2 (< 25%), type6 & 7 (more than 25%)
Exclusion criteria
• Gastrointestinal disturbances due to other causes, e.g. pregnancy, cancer • If applicable, has been on medication for at least 2 months • Planned surgery, medication change in the next 3-4 months/ during the study • Intolerance or allergy to any of the ingredients in the Gut Relief Formula
Outcome results
None listed