Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT06381193
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics
Sponsor:
Centros de Investigación de Nutrición y Salud
Organization:
Study Overview
Official Title:
Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:
* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
* To evaluate the stool consistency after 8 weeks (Bristol scale).
* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.
Participants are randomized into the following groups:
* Group A: 20 assigned to probiotic + placebo
* Group B: 20 assigned to prebiotic + placebo
* Group C: 20 assigned to probiotic + prebiotic
* Group D: 20 assigned to the placebo + placebo
Participants took 4 units of product per day (2 of each assigned product) for 2 months.
* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
* To evaluate the stool consistency after 8 weeks (Bristol scale).
* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.
Participants are randomized into the following groups:
* Group A: 20 assigned to probiotic + placebo
* Group B: 20 assigned to prebiotic + placebo
* Group C: 20 assigned to probiotic + prebiotic
* Group D: 20 assigned to the placebo + placebo
Participants took 4 units of product per day (2 of each assigned product) for 2 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: