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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02234518
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 18-75; female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period
* BMI: 18.5 - 29.9 kg/m2
* Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):a). average Bristol stool type of 1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at least ONE of: straining on at least 25% of defaecations; sensation of incomplete evacuation on at least 25% of defaecations; sensation of anorectal obstruction / blockage on at least 25% of defaecations; use of manual manoeuvres on at least 25% of defaecations
* Cleveland Clinic constipation score (CCCS) of 8-20
* Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener
* Ability to understand the patient information sheet and instructions in Dutch, and able to provide informed consent
Exclusion Criteria:
* Subjects who report lactose intolerance and/or are allergic to soy or cow milk protein
* Pregnant or breast-feeding women
* Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Coeliac disease, chronic diarrhoea)
* Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (\<3 months), abdominal pain and stool positive for occult blood
* Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendicectomy
* Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease
* Chronic medication that in opinion of the investigator would impact gut motility
* Illness that may preclude the subject'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
* Subjects 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)
* Ongoing alcohol, drug, or medication abuse (anamnesis only)
* Self-reported symptoms of pelvic organ prolapse
* Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids
* Regular use of fiber supplementation (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
* Participation in another study with any investigational product within 3 months of screening
* 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:
NCT02234518
Study Brief:
Protocol Section:
NCT02234518