Effect of Broth & Co Beef Bone Broth on lower gastrointestinal disturbances: The Bone Broth Gut Study

Not Applicable

• Conditions: lower gastrointestinal tract disorders; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; inflammatory bowel disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12620000092998
• Lead Sponsor: AProf Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-03
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adults with moderate lower gastrointestinal disturbances
including constipation, diarrhea, bloating, troublesome flatulence, abdominal pain
Participants may experience one or multiple symptoms at least once a week for at least 3 months

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 net 3-4 months/during the study
Intolerance or allergy to any of the ingredients in the Beef Bone Broth

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms relief, including constipation, diarrhea, bloating, pain, reflux<br>measured by questionnaires<br>Questionnaires: Birmingham IBS Symptom Q, Bristol Stool Chart, Leeds Dyspepsia Q, Tolerability, other symptoms Q<br>Each validated questionnaire consists of multiple questions re multiple symptoms. Relief of the sum of all symptoms will provide the composite outcome measure studied. [Start of run-in phase (-4 weeks), Baseline, (0 weeks), 4 weeks and 8 weeks post-intervention commencement];Quality of Life<br>assessed by questionnaires: <br>IBS-QoL, GERD-QoL, GERD-Health related QoL[Start of run-in phase (-4 weeks), Baseline, (0 weeks), 4 weeks and 8 weeks post-intervention commencement, etc.];Intestinal permeability/ leaky gut: by urine test kit<br>Lactulose/Mannitol ratio[Baseline (0 weeks) and 8 weeks post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Pain <br>by VAS 10-point Likert scale[Start of run-in phase (-4 weeks), Baseline, (0 weeks), 4 weeks and 8 weeks post-intervention commencement];Food Trigger questionnaire[Start of run-in phase (-4 weeks), Baseline, (0 weeks) and 8 weeks post-intervention commencement]