Actively Recruiting
A Pilot Study of a Multi-Strain Liquid Probiotic in Individuals Self-reporting Constipation in the General Population
Led by Dr Anthony Hobson · Updated on 2025-12-18
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Constipation is a common digestive problem that many people face. While lifestyle changes like increasing fiber, hydration, and exercise are often suggested, some individuals are not satisfied with usual drug treatments. Researchers are studying a multi-strain live bacterial probiotic supplement to see if it can help improve symptoms and quality of life in people who report having constipation. This pilot study aims to include 20 participants to better understand how this probiotic may work for those with mild constipation. Participants will take 70 ml of the multi-strain liquid probiotic once daily on an empty stomach for 28 to 35 days. They are asked to wait 10 minutes after taking the supplement before eating or drinking. This study focuses on assessing changes in constipation symptoms and gut function during this treatment period. During the study, participants will be evaluated using the Patient Assessment of Constipation-Symptoms (PAC-SYM) before and after 28 days of probiotic use. Other assessments include quality of life measures, gut transit times, stool frequency and form, gastrointestinal symptoms, and gas production. Participants will also keep a daily bowel diary and follow pre-test preparations for gut transit studies. The study is designed to monitor symptom improvements and treatment adherence over about one month.
CONDITIONS
Brief Title
Multi-strain Probiotic Effects on Self-Reported Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided written informed consent before participating
- Cleveland Clinic constipation score (CCCS) of 9-16 at screening call
- Willing to discontinue all other constipation therapies and complete washout if needed
- Male or non-pregnant female aged 18 to 70 years
- Women of childbearing potential willing to use approved contraception methods or have had hysterectomy or vasectomised partner
- Able to communicate well with the investigator and comply with study requirements
- Capacity to understand written English
- Body mass index (BMI) between 18.5 and 39.9 kg/m2 inclusive
- Agree to follow pre-test preparation for the gut transit capsule study
You will not qualify if you...
- Pregnant or breastfeeding women
- Planning significant diet changes during the study period
- Diarrhoea within 7 weeks before screening
- Prior abdominal surgery involving bowel resection
- Prior bariatric surgery involving stomach resection or bypass
- Type 1 diabetes mellitus
- Known organic or structural gastrointestinal diseases such as coeliac disease, inflammatory bowel disease, diverticulitis, or small bowel strictures
- Irritable bowel syndrome with predominant pain symptom
- Difficulty swallowing capsules (oropharyngeal dysphagia)
- Any medical condition that may affect study safety or results as judged by investigator
- Use of prohibited medications without completing washout
- Insufficient English to complete daily bowel diary
- Allergy to any supplement components, motility bar, lactulose, or Zoe blue cookie
- Involvement in this study as staff or sponsor member
- Previous use of the probiotic Symprove
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 to 35 days
Participants take 70 ml of a multi-strain liquid probiotic daily for 28 to 35 days, following specific instructions to take it on an empty stomach upon waking and wait 10 minutes before eating or drinking.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
The Functional Gut Clinic
London, United Kingdom, NW1 6PU
Actively Recruiting
Research Team
F
Fay Rendall
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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