Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT07275866
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07275866
Study Brief:
Protocol Section:
NCT07275866