Multi-strain Probiotic Effects on Self-Reported Constipation

NCT07275866 | Recruiting

• 1 other identifier: FGC-25-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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, 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

Constipation; Probiotic; Probiotic Intervention

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Constipation-Symptoms (PAC-SYM)

  Number of participants with clinically meaningful change in PAC-SYM score (reduction of \>0.6 or \>0.75 points). The PAC-SYM questionnaire is a 12 item validated patient-reported measure of severity of constipation symptoms during the past two weeks.

  Pre-post comparison (28 days)

Secondary Outcomes (16)

• Patient Assessment of Constipation - Quality of Life (PAC-QoL)

  Pre-Post comparison (28 days)

• Participant Compliance

  Pre-Post comparison (28 days)

• Whole Gut Transit Time (ATMO)

  Pre-Post comparison (28 days)

• Whole Gut Transit Time (Blue-dye)

  Pre-Post comparison (28 days)

• Small Bowel Transit Time (ATMO)

  Pre-Post comparison (28 days)

Study Arms (1)

Multi-strain Liquid Probiotic

EXPERIMENTAL

70ml of a multi-strain liquid probiotic taken daily for 28-35 days

Dietary Supplement: Multi-strain probiotics

Interventions

Multi-strain probiotics DIETARY_SUPPLEMENT

28-35 days of 70 ml Symprove once daily, to be taken on an empty stomach upon waking. 10 minutes should be taken between ingestion of Symprove before eating and drinking.

Multi-strain Liquid Probiotic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 participants' 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.

You may not qualify if:

• Women who are pregnant and/or breastfeeding.
• Participants who are planning to significantly change their diet (e.g. weight loss program, becoming vegetarian) during the study period.
• Participant has had diarrhoea within 7 weeks of screening period.
• Prior abdominal surgery involving resection of the small or large bowel.
• Prior bariatric surgery involving resection of the stomach or by-pass procedures.
• Type 1 diabetes mellitus.
• Known organic or structural GI disease including:
• Coeliac disease
• Inflammatory bowel disease
• Diverticulitis
• Small bowel strictures
• Irritable bowel syndrome where the predominant symptom is pain (assessed via screening questions).
• Oropharyngeal dysphagia or difficulty swallowing capsules.
• Any other medical condition that the investigator deems may confound results or affect participants' safety in the study.
• Any use of prohibited medication that the participant cannot complete appropriate washout for.

Sponsors & Collaborators

• Dr Anthony Hobson: lead

Study Sites (1)

The Functional Gut Clinic

London, NW1 6PU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fay Rendall

CONTACT

+441613027777; research@thefunctionalgutclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director and Senior Clinical GI Scientist

Model Details: The study is a single arm open label treatment. The study comprises of a 2 week baseline period followed by a 4 week treatment period.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: October 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Locations

GB (1)