The Clinical Evaluation of deactivated Bacillus subtilis BG01-4™ in subjects with Functional Gastrointestinal Disorder (FGID).

Not Applicable

Completed

• Conditions: Functional abdominal bloating/distension; Functional diarrhoea; Functional constipation; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621001441808
• Lead Sponsor: Dr Craig Patch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-25
• Study Completion: 2022-11-30
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Participants are self-reported functional gastrointestinal disorder in the last 3 months, and have one or more of the following self-reported symptoms experienced for the at least 6 months or longer (meeting the ROME IV criteria for functional gastrointestinal disorder):

a) Recurrent stomach bloating and/or distension occurring on average at least 1 day/week; andabdominal bloating and/or distension predominates over other symptoms, such as minorbowel movement abnormalities.

b) Loose or watery stools, without predominant abdominal pain or bothersome bloating,occurring in more than 25% of stools. (However if you have been diagnosed with IBS-D(diarrhea-predominant IBS) will not be eligible for this study).

c) Functional constipation: straining during more than 25% of defecation per week; sensation ofanorectal obstruction/blockage or incomplete evacuation more than 25% of defecations;needing manual maneuvers (e.g., digital assistance) to help with more than 25% of defecations;loose stools are rare without the use of laxatives.

Exclusion Criteria

a) Participants who had a clinical diagnosis of irritable bowel disease (IBD)
b) Participants who have opioid-induced constipation (OIC).
c) Participants who are intolerant to maltodextrin (food ingredient).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of experiencing abdominal bloating/distension using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, <br><br>The Gastrointestinal Symptom Rating Scale (GSRS) is a disease-specific questionnaire of 15 items to assess the severity and frequency of symptoms was reported; GSRS uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem.[Changes from Baseline, mid (15th day) and 30th day,];Change in severity of experiencing diarrhoea using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, [Changes from Baseline, mid (15th day) and 30th day,];Change in severity of experiencing constipation using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, [Changes from Baseline, mid (15th day) and 30th day,]

Secondary Outcome Measures

Name	Time	Method
The degree of microbiota change assessed using 16S DNA sequencing.[Changes from Baseline and 30th day,];Change in severity of experiencing heartburn using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, [Changes from Baseline and 30th day,];Change in severity of experiencing acid reflux using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, [Changes from Baseline and 30th day,];Change in severity of experiencing nausea using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, [Changes from Baseline and 30th day,];Change in severity of experiencing abdominal pain using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms, [Changes from Baseline and 30th day]