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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT04587635
Eligibility Criteria:
Inclusion criteria:
1. Men or women aged 18-75, inclusive.
2. Self-reported symptoms of constipation for a minimum of 3 months.
3. Constipation symptoms according to the adapted Rome IV Diagnostic Questionnaire for Adults for Functional Constipation (Appendix 2) administered at screening.
4. Cleveland Clinic constipation score (CCCS) of 8-20.
5. Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener completed by site personnel.
6. Ability to understand the participant information sheet and instructions, and able to provide informed consent.
7. Access to a suitable smartphone device (Android or iOS) with ability to download and complete the study e-Diary daily for the duration of the trial.
Exclusion criteria:
1. Pregnant women or breastfeeding.
2. Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Ulcerative Colitis, Coeliac disease, chronic diarrhoea).
3. Any clinically relevant abnormalities in the screening visit physical examination or alarm features in the medical history such as sudden unintentional weight loss (\>10% in 3 months), frequent rectal bleeding not caused by anal fissures or hemorrhoids, recent change in bowel habit (\<3 months), severe abdominal pain and stool positive for occult blood.
4. Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendectomy.
5. Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease.
6. Chronic usage of any medication that in the opinion of the investigator would impact gut motility two weeks prior to the initial administration of study product or up to a minimum of 5 times the half-life of the medication if it has a long half-life.
7. Illness that may preclude the participant's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in \>2 weeks inability to work in the 3 months before the study start.
8. Participants with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility).
9. Ongoing alcohol, drug, or medication abuse (anamnesis only).
10. Self-reported symptoms of pelvic organ prolapse, such as feeling of pressure or fullness in the pelvic area, intra vaginal discomfort, painful intercourse and urinary problems.
11. Moderate or severe active local anorectal problems such as recurrent anal fissures, frequent bleeding, large prolapsing haemorrhoids.
12. Regular use of fiber (e.g. Fybogel, Lactulose) (i.e. no more than 1 standard dose) over the week prior to the screening visit and no more than 6 standard doses in the past 1 month prior to the screening visit.
13. Consumption of any type of yoghurts or probiotic-containing products, i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Saccharomyces such as Activia, Actimel, Yakult, in the 4 weeks prior to randomization (V0).
14. Participation in another study with any investigational product within 6 months of screening.
15. Participation in another constipation trial in the past year.
16. Investigator believes that the participant is physically or mentally unfit to participate in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04587635
Study Brief:
Protocol Section:
NCT04587635