Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation
Cerebral Palsy, Chronic Constipation
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, children, chronic constipation, synbiotic, prebiotics, probiotics, agave inulin, microbiota
Eligibility 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.
Sites / Locations
- Nuevo Hospital Civil de Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Synbiotic
Probiotic
Prebiotic
Placebo
Each participant will receive the next: agave inulin (4 g) in powder Lactobacillus reuteri DSM 17938 (1 x 10^8 cfu) in 5 drops daily, once a day for four weeks.
Lactobacillus reuteri DSM 17938 (1 x 10^8 cfu) in 5 drops and maltodextrin (4 g) in powder daily, once a day for four weeks.
agave inulin (4 g) in powder and an oil mix (sunflower oil and medium chain triglyceride oil) in 5 drops daily, once a day for four weeks.
maltodextrin (4 g) in powder and an oil mix (sunflower oil and medium chain triglyceride oil) in 5 drops daily, once a day for four weeks.