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Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation

NCT03117322 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-12-26

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Chronic Constipation

Interventions

BIOLOGICAL

agave inulin

Duration: four weeks Dosage: powder 4 g/d

BIOLOGICAL

Lactobacillus reuteri DSM 17938

Duration: four weeks Dosage: 5 drops/d

OTHER

maltodextrin

Duration: four weeks Dosage: powder 4 g/d

OTHER

Oil mix (medium chain triglycerides and sunflower oil)

Duration: four weeks Dosage: 5 drops/d

Sponsors & Collaborators

  • Andrea Garcia Contreras

    lead OTHER

Principal Investigators

  • Edgar M Vásquez-Garibay, Doctor · full time staff member at the Division of Pediatrics of the New Civil Hospital of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2018-12-21
Completion
2018-12-21

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117322 on ClinicalTrials.gov