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

Primary Purpose

Cerebral Palsy, Chronic Constipation

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
agave inulin
Lactobacillus reuteri DSM 17938
maltodextrin
Oil mix (medium chain triglycerides and sunflower oil)
Sponsored by
Andrea Garcia Contreras
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Synbiotic

Probiotic

Prebiotic

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)
species/g
change in consistency of feces
Bristol scale
change in potential of hydrogen (pH) of feces
pH scale
change in frequency of evacuations
evacuations per week

Secondary Outcome Measures

change in the concentration of short chain fatty acids in feces
millimoles (mM)

Full Information

First Posted
April 10, 2017
Last Updated
December 21, 2018
Sponsor
Andrea Garcia Contreras
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1. Study Identification

Unique Protocol Identification Number
NCT03117322
Brief Title
Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrea Garcia Contreras

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Chronic Constipation
Keywords
cerebral palsy, children, chronic constipation, synbiotic, prebiotics, probiotics, agave inulin, microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
Three interventions in parallel against a control group
Masking
ParticipantCare ProviderInvestigator
Masking Description
pediatric neurologist and laboratory staff.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synbiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
agave inulin
Intervention Description
Duration: four weeks Dosage: powder 4 g/d
Intervention Type
Biological
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Intervention Description
Duration: four weeks Dosage: 5 drops/d
Intervention Type
Other
Intervention Name(s)
maltodextrin
Intervention Description
Duration: four weeks Dosage: powder 4 g/d
Intervention Type
Other
Intervention Name(s)
Oil mix (medium chain triglycerides and sunflower oil)
Intervention Description
Duration: four weeks Dosage: 5 drops/d
Primary Outcome Measure Information:
Title
Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)
Description
species/g
Time Frame
change from baseline bacteria composition at four weeks
Title
change in consistency of feces
Description
Bristol scale
Time Frame
change from baseline consistency at four weeks
Title
change in potential of hydrogen (pH) of feces
Description
pH scale
Time Frame
Change from baseline pH at four weeks
Title
change in frequency of evacuations
Description
evacuations per week
Time Frame
change from baseline frequency at four weeks
Secondary Outcome Measure Information:
Title
change in the concentration of short chain fatty acids in feces
Description
millimoles (mM)
Time Frame
Change from baseline concentration at four weeks
Other Pre-specified Outcome Measures:
Title
Change in Body weight
Description
Kg
Time Frame
Change from baseline weight at four weeks
Title
length
Description
cm
Time Frame
Baseline
Title
Change of Dietary fiber intake
Description
grams
Time Frame
Change from baseline dietary fiber intake at four weeks
Title
Change of dietary Liquids
Description
milliliters (mL)
Time Frame
Change from baseline liquids at four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar M Vásquez-Garibay, Doctor
Organizational Affiliation
full time staff member at the Division of Pediatrics of the New Civil Hospital of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuevo Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25531996
Citation
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Citation
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Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://drive.google.com/file/d/0B2DsNKWyL7bfNUo4NkVPd3V0aHc/view?usp=sharing
Available IPD/Information Comments
Just a google drive link to download the informed consent form in pdf.

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

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