Multi-strain probiotic for self-reported constipation

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

This tests whether a multi-strain probiotic helps adults aged 18–70 with moderate constipation (Cleveland Clinic constipation score 9–16).

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Functional Gut Clinic (other)
• Locations: 1 site (London)
• Trial ID: NCT07275866 on ClinicalTrials.gov

What this trial studies

Adults aged 18–70 with moderate constipation (CCCS 9–16) who agree to stop other constipation therapies will receive a multi-strain probiotic containing billions of live bacteria. Participants will report symptoms over the treatment period using self-reported constipation measures to track changes in bowel habits and related symptoms. Investigators aim to relate symptom patterns and underlying pathophysiology to probiotic response to help target treatment in the future. The interventional program is conducted at the Functional Gut Clinic in London and requires in-person attendance for screening and follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 with moderate constipation (CCCS 9–16) who are willing to stop other constipation treatments and can attend the Functional Gut Clinic in London.

Not a fit: People with very severe or secondary causes of constipation, pregnant individuals, those outside the 18–70 age range, or those unwilling to discontinue other therapies may not receive benefit.

Why it matters

Potential benefit: If successful, this could provide a non-drug, microbiome-targeted option that improves bowel symptoms for some people with constipation.

How similar studies have performed: Previous trials of pre-, pro- and synbiotics have shown benefit for some patients with mild constipation or IBS-C, but responses are inconsistent and predictors of benefit are not established.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Participant has Cleveland Clinic constipation score (CCCS) of 9-16 at screening call
3. Participant is willing to discontinue all other therapies for constipation and undergo washout where applicable.
4. Participant is a male or non-pregnant female and is 18-70 years of age
5. 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 participants' preferred and usual lifestyle).

   or has had a: v) Hysterectomy or has a: vi) Vasectomised partner
6. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
7. Participant has capacity to understand written English.
8. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
9. Participant agrees to follow all pre-test preparation for the ATMO capsule transit study.

Exclusion Criteria:

1. Women who are pregnant and/or breastfeeding.
2. Participants who are planning to significantly change their diet (e.g. weight loss program, becoming vegetarian) during the study period.
3. Participant has had diarrhoea within 7 weeks of screening period.
4. Prior abdominal surgery involving resection of the small or large bowel.
5. Prior bariatric surgery involving resection of the stomach or by-pass procedures.
6. Type 1 diabetes mellitus.
7. Known organic or structural GI disease including:

   * Coeliac disease
   * Inflammatory bowel disease
   * Diverticulitis
   * Small bowel strictures
8. Irritable bowel syndrome where the predominant symptom is pain (assessed via screening questions).
9. Oropharyngeal dysphagia or difficulty swallowing capsules.
10. Any other medical condition that the investigator deems may confound results or affect participants' safety in the study.
11. Any use of prohibited medication that the participant cannot complete appropriate washout for.
12. Insufficient knowledge of English to complete the daily bowel diary.
13. Allergy to any component of the supplement, motility bar, lactulose or Zoe blue cookie.
14. Participant is involved in this study as an investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
15. Previous use of the probiotic Symprove.

Where this trial is running

London

• The Functional Gut Clinic — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Fay Rendall

Conditions: Constipation, Probiotic, Probiotic Intervention