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New treatment option for Constipation
Official title Multi-strain Probiotic Effects on Self-Reported Constipation
ClinicalTrials.gov ID: NCT07275866
What this study is testing
- What it's testing
- Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to...
- 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...
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.