ConstipationNCT07275866
Multi-strain Probiotic Effects on Self-Reported Constipation
A study testing Multi-strain probiotics in people with Constipation and Probiotic, run by Dr Anthony Hobson at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation, Probiotic, Probiotic Intervention
- What is being tested?
- Multi-strain probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Insufficient knowledge of English to complete the daily bowel diary.
- Allergy to any component of the supplement, motility bar, lactulose or Zoe blue cookie.
- Participant is involved in this study as an investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
- Previous use of the probiotic Symprove.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of a Multi-Strain Liquid Probiotic in Individuals Self-reporting Constipation in the General Population.
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.
Read more
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
- Being tested
- Multi-strain probiotics
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probioticsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-strain Liquid Probiotic | Experimental | 70ml of a multi-strain liquid probiotic taken daily for 28-35 days Receives: Dietary Supplement: Multi-strain probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-post comparison (28 days)
Secondary outcomes (16)
Patient Assessment of Constipation - Quality of Life (PAC-QoL)
Number of participants with clinically meaningful change in PAC-QoL (reduction of >0.5 or >1.0 point).
A validated questionnaire consisting of 28 items to measure the impact of constipation on a patient's quality of life.
Measured: Pre-Post comparison (28 days)
Participant Compliance
Number of participants completing >75% of breath gas measurements and bowel diary submissions with OMED device.
The OMED Health Breath Analyzer is used for breath gas readings at 4 intervals during the day. The bowel diary recorded daily on paper throughout the study capturing movements, symptoms and any medication
Measured: Pre-Post comparison (28 days)
Whole Gut Transit Time (ATMO)
Change in whole gut transit time measured by ATMO capsule
ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract.
Measured: Pre-Post comparison (28 days)
Whole Gut Transit Time (Blue-dye)
Change in whole gut transit time measured by Blue dye transit study baseline period to treatment period.
Participants are required to consume a Zoe blue cookie the following morning after both visits 2 and 3. Participants then report when the blue food colour is visible in their stool, checking every time they pass a bowel movement.
Measured: Pre-Post comparison (28 days)
Small Bowel Transit Time (ATMO)
Change in small bowel transit time measured by ATMO capsule
ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract.
Measured: Pre-Post comparison (28 days)
Large Bowel Transit Time (ATMO)
Change in large bowel transit time measured by ATMO capsule
ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract.
Measured: Pre-Post comparison (28 days)
Gastrointestinal Symptom Rating Scale (GSRS)
Mean change in GSRS score
A validated questionnaire consisting of 15items to assess range of GI symptoms. Scored using a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
Measured: Pre-Post comparison (28 days)
Stool form comparison
Average stool type recorded in two week baseline compared to average stool type recorded final two weeks of treatment period. Measured using the bristol stool chart reported in bowel habit diary.
Measured: Pre-Post comparison (days 1-14 compared to days 29-42)
Stool frequency comparison
Average stool frequency recorded in two week baseline compared to average stool type recorded final two weeks of treatment period reported in bowel habit diary.
Measured: Pre-Post comparison (days 1-14 compared to days 29-42)
Hydrogen and methane production
Assessment of longitudinal hydrogen and methane production during baseline and treatment periods. Recorded by OMED device 4x daily
Measured: Pre-Post comparison (days 1-14 compared to days 15-42)
Global PAC-SYM
Comparison of global PAC-SYM score from baseline period to treatment period.
Measured: Pre-Post comparison (28 days)
Inidividual PAC-SYM
Comparison of individual PAC-SYM symptom scores from baseline period to treatment period.
Measured: Pre-Post comparison (28 days)
Straining
Self reported straining recorded in two week baseline compared to self reported straining during treatment period reported in bowel habit diary.
Measured: Pre-Post comparison (days 1-14 compared to days 15-42)
Sense of complete evacuation
Self reported sense of complete evacuation recorded in two week baseline compared to self reported Sense of complete evacuation during treatment period reported in bowel habit diary.
Measured: Pre-Post comparison (days 1-14 compared to days 15-42)
Time taken for evacuation
Self reported time taken for evacuation recorded in two week baseline compared to self reported time taken for evacuation during treatment period reported in bowel habit diary.
Measured: Pre-Post comparison (days 1-14 compared to days 15-42)
Rescue Medication
Self reported use of rescue medication recorded in two week baseline compared to self reported use of rescue medication during treatment period reported in bowel habit diary.
Measured: Pre-Post comparison (days 1-14 compared to days 15-42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start3 Oct 2025
- Primary completion20 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Anthony Hobson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Anthony Hobson, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275866
- Sponsor's protocol ID
- FGC-25-02
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Multi-Strain Liquid Probiotic in Individuals Self-reporting Constipation in the General Population.
- ClinicalTrials.gov ID
- NCT07275866
- Acronym / sponsor ID
- FGC-25-02
- Conditions
- Constipation, Probiotic, Probiotic Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr Anthony HobsonUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multi-strain Liquid Probiotic | Experimental | Dietary Supplement: Multi-strain probiotics70ml of a multi-strain liquid probiotic taken daily for 28-35 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-strain probiotics28-35 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. | Dietary supplement | Multi-strain Liquid Probiotic |
Primary outcome
Patient Assessment of Constipation-Symptoms (PAC-SYM)
Time frame: Pre-post comparison (28 days)
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.
16 secondary outcomes
Patient Assessment of Constipation - Quality of Life (PAC-QoL)
Time frame: Pre-Post comparison (28 days)
Participant Compliance
Time frame: Pre-Post comparison (28 days)
Whole Gut Transit Time (ATMO)
Time frame: Pre-Post comparison (28 days)
Whole Gut Transit Time (Blue-dye)
Time frame: Pre-Post comparison (28 days)
Small Bowel Transit Time (ATMO)
Time frame: Pre-Post comparison (28 days)
Large Bowel Transit Time (ATMO)
Time frame: Pre-Post comparison (28 days)
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Pre-Post comparison (28 days)
Stool form comparison
Time frame: Pre-Post comparison (days 1-14 compared to days 29-42)
Stool frequency comparison
Time frame: Pre-Post comparison (days 1-14 compared to days 29-42)
Hydrogen and methane production
Time frame: Pre-Post comparison (days 1-14 compared to days 15-42)
Global PAC-SYM
Time frame: Pre-Post comparison (28 days)
Inidividual PAC-SYM
Time frame: Pre-Post comparison (28 days)
Straining
Time frame: Pre-Post comparison (days 1-14 compared to days 15-42)
Sense of complete evacuation
Time frame: Pre-Post comparison (days 1-14 compared to days 15-42)
Time taken for evacuation
Time frame: Pre-Post comparison (days 1-14 compared to days 15-42)
Rescue Medication
Time frame: Pre-Post comparison (days 1-14 compared to days 15-42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-strain probiotics in people with Constipation and Probiotic, run by Dr Anthony Hobson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Constipation-Symptoms (PAC-SYM) (time frame: Pre-post comparison (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.