Effect of Nutrition-Care Gut Relief Formula on Gastrointestinal Disturbances: The Gut Relief Study

Not Applicable

Completed

• Conditions: moderate gastrointestinal disturbances of the upper or lower gastrointestinal tract; dyspepsia; Oral and Gastrointestinal - Inflammatory bowel disease; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12618000878279
• Lead Sponsor: A/Prof Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-23
• Study Completion: 2019-05-03
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom Relief<br>measured by questionnaires<br>Questionnaires: Dyspepsia Leeds Short Form, Bristol stool chart, Birmingham IBS Symptom Q, GERD-Q Symptom Score, Pain-VAS scale, Tolerability, other symptoms Q[12, 8, 4 weeks of intervention compared to baseline (0 weeks) and before run-in phase (-4 weeks)];Quality of Life<br>assessed by questionnaires: IBS-QoL, GERD-QoL, GERD-Health related QoL[12, 8, 4 weeks of intervention compared to baseline (0 weeks) and before run-in phase (-4 weeks)];Composite primary outcome: Microbial Character by Stool test by multiplex PCR-DNA analysis to assess microbial richness and microbial diversity, and Firmicute/Bacteroides Ratio[12 weeks of intervention compared to baseline (0 weeks) after run-in phase]

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers by serum assay:<br>TNF-alpha, IL-1 beta, IL6, IL8[12 weeks of intervention compared to baseline (0 weeks) after run-in phase];Intestinal permeability/ leaky gut: by urine test kit<br>Lactulose/Mannitol ratio[12 weeks of intervention compared to baseline (0 weeks) after run-in phase]