A Pilot Study of a Multi-Strain Liquid Probiotic in Individuals Self-reporting Constipation in the General Population.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g. increasing fibre intake, hydration, levels of exercise), medical therapies are available for management. However, a sizeable number of sufferers are dissatisfied with drug treatments (either over-the-counter or prescribed), meaning there is an unmet need for alternative therapeutic strategies. Pre, pro- and synbiotics have emerged as one alternative treatment, and a growing body of evidence now supports their use in a proportion of individuals with mild constipation. However, we are currently unable to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment. We are testing a multistrain live bacterial food product (probiotic) containing billions of live and active bacteria that has been shown to improve symptoms in the irritable bowel syndrome (IBS: which is 'constipation-predominant' in many). Notably, improvements ('completely resolved' or 'some positive difference') in bowel habit satisfaction, abdominal pain, bloating and urgency, as well as on quality of life have been shown after 4 or more weeks of this probiotc. This study aims to have 20 participants with self-reported constipation to assess improvements in constipation symptoms, quality of life and measures of gut function.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.

• Participant has Cleveland Clinic constipation score (CCCS) of 9-16 at screening call

• Participant is willing to discontinue all other therapies for constipation and undergo washout where applicable.

• Participant is a male or non-pregnant female and is 18-70 years of age

• If WOCBP participant is willing to adhere to one of the following methods of contraception:

• i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) vi) Sexual abstinence (if it is in line with your preferred and usual lifestyle).

• or has had a: v) Hysterectomy or has a: vi) Vasectomised partner

• Participant can communicate well with the Investigator and to comply with the requirements for the entire study.

• Participant has capacity to understand written English.

• Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).

• Participant agrees to follow all pre-test preparation for the ATMO capsule transit study.

Locations
Other Locations
United Kingdom
The Functional Gut Clinic
RECRUITING
London
Contact Information
Primary
Fay Rendall
research@thefunctionalgutclinic.com
+441613027777
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2026-04
Participants
Target number of participants: 20
Treatments
Experimental: Multi-strain Liquid Probiotic
70ml of a multi-strain liquid probiotic taken daily for 28-35 days
Related Therapeutic Areas
Sponsors
Leads: Dr Anthony Hobson

This content was sourced from clinicaltrials.gov