CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
agave inulin +3 morebiological
Likely dose
agave inulin 4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03117322
NCT03117322Phase 4Completed

Efficacy of the Supplementation With a Symbiotic, a Prebiotic and a Probiotic to Produce a Beneficial Effect on the Intestinal Microbiota and on the Characteristics of Feces in Children With Cerebral Palsy (CP) and Chronic Constipation

Andrea Garcia Contreras·interventional·Posted Apr 17, 2017·Updated Dec 26, 2018

In Brief

A Phase 4 clinical trial evaluating agave inulin, Lactobacillus reuteri DSM 17938, and 2 other interventions for Cerebral Palsy and Chronic Constipation. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Randomized double blind controlled clinical trial. Participants will be enrolled at the New Civil Hospital of Guadalajara "Dr. Juan I. Menchaca" during the period from May 2017 to July 2018, from six to 59 months of either sex. The duration of each participant in the study will be of four weeks. Each participant will be randomized assigned to any of the different study groups: synbiotic, prebiotic, probiotic or placebo. Hypothesis: The efficacy of supplementation with a symbiotic, a prebiotic and a probiotic differs in its beneficial effect on the intestinal microbiota and the characteristics of feces in children with CP and chronic constipation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 17, 2017
Enrollment StartJun 5, 2017
Primary CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.2 years ago

Interventions

agave inulinbiological

Duration: four weeks Dosage: powder 4 g/d

Lactobacillus reuteri DSM 17938biological

Duration: four weeks Dosage: 5 drops/d

maltodextrinother

Duration: four weeks Dosage: powder 4 g/d

Oil mix (medium chain triglycerides and sunflower oil)other

Duration: four weeks Dosage: 5 drops/d