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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03117322
• Date of registration: 10/04/2017
• Prospective Registration: Yes
• Primary sponsor: Andrea Garcia Contreras
• Public title: Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation
• Scientific title: 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
• Date of first enrolment: June 5, 2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03117322
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants attending the outpatient of nutrition and/or pediatric neurology with
cerebral palsy diagnosed and confirmed by a pediatric neurologist, and that belong to
levels IV or V of the Gross Motor Function Classification System (GMFCS).

- Participants with constipation according to the Rome IV criteria.

- Signed informed consent by one of the child's parents or legal guardians

Exclusion Criteria:

- Refusal to continue in the study

- Use of antibiotics during the study, consumption of laxatives, food fibers, lactulose,
magnesia or products containing probiotics, prebiotics or both as infant formulas
(NOTE: Glycerin suppositories will only be allowed when there is no evacuation for
more than five days).

- Omission of administration of the required dose of symbiotic, prebiotic, probiotic or
placebo and/or administered with an unspecified frequency (compliance <95%)

- Adverse effects not related to the agent of study.



Age minimum: 6 Months
Age maximum: 60 Months
Gender: All

Health Condition(s) or Problem(s) studied

Cerebral Palsy

Chronic Constipation

Intervention(s)

Biological: agave inulin

Other: maltodextrin

Other: Oil mix (medium chain triglycerides and sunflower oil)

Biological: Lactobacillus reuteri DSM 17938

Primary Outcome(s)

change in consistency of feces [Time Frame: change from baseline consistency at four weeks]

Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli) [Time Frame: change from baseline bacteria composition at four weeks]

change in potential of hydrogen (pH) of feces [Time Frame: Change from baseline pH at four weeks]

change in frequency of evacuations [Time Frame: change from baseline frequency at four weeks]

Secondary Outcome(s)

change in the concentration of short chain fatty acids in feces [Time Frame: Change from baseline concentration at four weeks]

Secondary ID(s)

0167/17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors