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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT02073006
Eligibility Criteria:
Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must;
1. Be able to give written informed consent,
2. Be between 18 and 80 years of age,
3. Subject has chronic functional constipation according to the Rome III Diagnostic Criteria, where (f) is mandatory.
i. Must include two or more of the following:
1. Straining during at least 25% of defæcations
2. Lumpy or hard stools in at least 25% of defæcations
3. Sensation of incomplete evacuation for at least 25% of defæcations
4. Sensation of anorectal obstruction / blockage for at least 25% of defaecations
5. Manual manœuvers to facilitate at least 25% of defæcations (e.g., digital evacuation, support of the pelvic floor)
6. Fewer than 3 defæcations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome \* Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis
4. Subjects will continue on his/her normal diet,
5. The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
1. Are less than 18 and greater than 80 years of age,
2. Females are pregnant, lactating or wish to become pregnant during the study.
3. Are hypersensitive to any of the components of the test product,
4. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
5. Subject has an obstructive or metabolic aetiology for constipation,
6. Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
7. Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit,
8. Subject has a history of drug and/or alcohol abuse at the time of enrolment
9. Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
11. Subjects may not be receiving treatment involving experimental drugs,
12. If the subject has been in a recent experimental trial, these must have been completed not less than 90 days prior to this study.
13. Have a malignant disease or any concomitant end-stage organ disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02073006
Study Brief:
Protocol Section:
NCT02073006