Modulation of the Gastrointestinal Microbiome with probiotics and subsequent Methane production as a novel approach to treat constipatio

Not Applicable

Recruiting

• Conditions: constipation; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620001148965
• Lead Sponsor: Metro South Hosptial and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-02
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

18 years of age and older
Presence of constipation symptoms for at least 6 months and in the first instance a baseline methane exhalations > 10 ppm.

Exclusion Criteria

Patients younger than 18 years and older than 80 years of age.
Exclusion of any relevant conditions that can interfere with the study objectives including:
Medical co morbidities that are related to constipation
Diagnosis of diabetes
Previous surgery that may account for constipation
Receiving ongoing antibiotic treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire- constipation severity[ Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline];Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) – impact of Constipation [ Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline];Methane production is assessed via a hydrogen breath test after a glucose test meal[ Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline]