Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-03 @ 8:20 PM
Study NCT ID:
NCT04028258
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
Sponsor:
Laboratorios Ordesa
Organization:
Study Overview
Official Title:
Randomized, Controlled, Crossover, Double-blind Clinical Trial on the Effect of a Mixture of Plant-based Fibers and Carbohydrates on Intestinal Transit in Children Aged 3 to 12 Diagnosed With Functional Constipation
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
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:
VEGY-DOWN(A)
Brief Summary:
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:
* Group A: study product+wash out+control product
* Group B: control product+wash out+study product
* Group A: study product+wash out+control product
* Group B: control product+wash out+study product
Detailed Description:
All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.
* Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.
* Control: Placebo supplement: maltodextrin and plum flakes
* Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.
* Control: Placebo supplement: maltodextrin and plum flakes
Study Oversight
Has Oversight DMC:
False
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?: