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

December 21, 2018 updated by: Andrea Garcia Contreras

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All the data registered in the case report forms will be monitored by the responsible party. This person will be monitoring each procedure during the study.

All the data in the case report forms will be obtained from the information obtained from the legal caregiver or the parents of the child and/or from the medical and electronic records and calls to the parents or legal caregivers and will be introduced daily in the Statistical Package for the Social Scienses (SPSS) program version 21. The responsible party will have access to this database and will verify the information.

Plan for missing data. In case that we have some missing variables, we will call the parents or legal caregiver of the children if it is about the data of the child. In case of missing data, unavailable or non-reported variable and it is not possible to compare the initial vs final phases, the subject will be excluded from the study. In case of finding an out-of-range laboratory results we will repeat the test. If we have some missing data from the subject but we can analyze other results from the same subject, it will not be excluded.

Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. Patients will be recruited from the nutrition and neurology outpatient at the New Hospital Civil of Guadalajara. We will apply a standardized questionnaire to the parents or legal caregivers to assure that the subject could be eligible to the study. Once all the inclusion criteria are fulfilled then another questionnaire or case report form will be filled. The informed consent will be explained and given to the parents or legal caregivers of the child for sign. An external person will be chose to assign randomly (by envelops) the subjects to each group. This person will provide the study product and the diaries to the parents or legal caregivers. Data from the case reports forms will be captured by the principal investigator and monitored by the responsible party. Te adverse events will be reported by phone calls during the four weeks (two to three phone calls in a week). To analyze the information, the SPSS program version 21 will be used.

Sample size. The sample size was calculated according to the next formula:

n= K (σ12 + σ22)/ (μ1 - μ2) 2 = 6.2 (1.12 + 0.62)/ (4.01 - 2.8) n= 7 + 3 (30% probability of exclusion) = 10 children for each group, total subjects in the study: 40.

α= 0.05 β= 0.20 Data was obtained from the study of Indrio F, et al (2014) 18 with the number of evacuation.

Sampling system. Simple random sample by means of closed envelopes with a figure inside. We will have 40 envelopes closed, 10 of them will have a circle, 10 a triangle, 10 a star and 10 a heart. They will be put into a box; this will be rotated five times before taking an envelope. Randomly, a person outside the study will take an envelope, will see the chosen figure and will write it down in the register.

Statistical analysis. First stage. Shapiro Wilk test will be performed to see the distribution of the data. Descriptive statistics: mean, standard deviation, percentages and frequencies will be performed. Second stage. Analytical statistics: Intra-groups: Student's T test for dependent samples for parametric data or the Wilcoxon test for non-parametric data. Chi square for analysis of qualitative data. Inter-groups: One-way ANOVA with post hoc (Bonferroni) tests. If the data are not parametric, Kruskal-Wallis and if it is significant, Mann Whitney's U will be performed as post hoc. Third stage. Linear regression and logistic regression will be performed.

Ethical considerations. Parents or legal representatives of the child will be informed about the study, requesting their signature for consent. Human research guidelines will be respected according to "good clinical practice". The protocol will be submitted to the Bioethics Committee of the New Civil Hospital of Guadalajara and the University of Guadalajara. Care will be taken to respect the recommendations of the Helsinki Declaration in its last correction made during the 64th Annual Assembly organized by the World Medical Association (2013).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Nuevo Hospital Civil de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Synbiotic

Each participant will receive the next:

  1. agave inulin (4 g) in powder
  2. Lactobacillus reuteri DSM 17938 (1 x 10^8 cfu) in 5 drops daily, once a day for four weeks.
Biological: agave inulin
Duration: four weeks Dosage: powder 4 g/d
Biological: Lactobacillus reuteri DSM 17938
Duration: four weeks Dosage: 5 drops/d
EXPERIMENTAL: Probiotic
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.
Biological: Lactobacillus reuteri DSM 17938
Duration: four weeks Dosage: 5 drops/d
Other: maltodextrin
Duration: four weeks Dosage: powder 4 g/d
EXPERIMENTAL: Prebiotic
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.
Biological: agave inulin
Duration: four weeks Dosage: powder 4 g/d
Other: Oil mix (medium chain triglycerides and sunflower oil)
Duration: four weeks Dosage: 5 drops/d
PLACEBO_COMPARATOR: Placebo
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)
Time Frame: change from baseline bacteria composition at four weeks
species/g
change from baseline bacteria composition at four weeks
change in consistency of feces
Time Frame: change from baseline consistency at four weeks
Bristol scale
change from baseline consistency at four weeks
change in potential of hydrogen (pH) of feces
Time Frame: Change from baseline pH at four weeks
pH scale
Change from baseline pH at four weeks
change in frequency of evacuations
Time Frame: change from baseline frequency at four weeks
evacuations per week
change from baseline frequency at four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the concentration of short chain fatty acids in feces
Time Frame: Change from baseline concentration at four weeks
millimoles (mM)
Change from baseline concentration at four weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body weight
Time Frame: Change from baseline weight at four weeks
Kg
Change from baseline weight at four weeks
length
Time Frame: Baseline
cm
Baseline
Change of Dietary fiber intake
Time Frame: Change from baseline dietary fiber intake at four weeks
grams
Change from baseline dietary fiber intake at four weeks
Change of dietary Liquids
Time Frame: Change from baseline liquids at four weeks
milliliters (mL)
Change from baseline liquids at four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea Garcia Contreras

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 5, 2017

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (ACTUAL)

April 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0167/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Informed Consent Form
    Information comments: Just a google drive link to download the informed consent form in pdf.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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