Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07275866

Multi-strain Probiotic Effects on Self-Reported Constipation

Led by Dr Anthony Hobson · Updated on 2025-12-18

20

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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, it is currently not possible to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment. The multistrain live bacterial food product (probiotic) being tested contains 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.

CONDITIONS

Official Title

Multi-strain Probiotic Effects on Self-Reported Constipation

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 woman of childbearing potential, participant is willing to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, sexual abstinence, has had hysterectomy, or has a vasectomised partner.
  • Participant can communicate well with the Investigator and comply with the study requirements.
  • Participant has capacity to understand written English.
  • Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2.
  • Participant agrees to follow all pre-test preparation for the ATMO capsule transit study.
Not Eligible

You will not qualify if you...

  • Women who are pregnant and/or breastfeeding.
  • Participants planning significant diet changes during the study period.
  • Participant has had diarrhoea within 7 weeks before screening.
  • Prior abdominal surgery involving removal of small or large bowel.
  • Prior bariatric surgery involving stomach resection or bypass.
  • Type 1 diabetes mellitus.
  • Known organic or structural gastrointestinal diseases including coeliac disease, inflammatory bowel disease, diverticulitis, or small bowel strictures.
  • Irritable bowel syndrome with predominant pain symptoms.
  • Difficulty swallowing capsules or oropharyngeal dysphagia.
  • Any medical condition that may affect study results or participant safety.
  • Use of prohibited medications without proper washout.
  • Insufficient English knowledge to complete daily bowel diary.
  • Allergy to any supplement components, motility bar, lactulose, or Zoe blue cookie.
  • Participant involved in the study staff or sponsor.
  • Previous use of the probiotic Symprove.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Functional Gut Clinic

London, United Kingdom, NW1 6PU

Actively Recruiting

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Research Team

F

Fay Rendall

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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