Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation
NCT ID: NCT03117322
Last Updated: 2018-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2017-06-05
2018-12-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
agave inulin
Duration: four weeks Dosage: powder 4 g/d
Lactobacillus reuteri DSM 17938
Duration: four weeks Dosage: 5 drops/d
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.
Lactobacillus reuteri DSM 17938
Duration: four weeks Dosage: 5 drops/d
maltodextrin
Duration: four weeks Dosage: powder 4 g/d
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.
agave inulin
Duration: four weeks Dosage: powder 4 g/d
Oil mix (medium chain triglycerides and sunflower oil)
Duration: four weeks Dosage: 5 drops/d
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.
maltodextrin
Duration: four weeks Dosage: powder 4 g/d
Oil mix (medium chain triglycerides and sunflower oil)
Duration: four weeks Dosage: 5 drops/d
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
agave inulin
Duration: four weeks Dosage: powder 4 g/d
Lactobacillus reuteri DSM 17938
Duration: four weeks Dosage: 5 drops/d
maltodextrin
Duration: four weeks Dosage: powder 4 g/d
Oil mix (medium chain triglycerides and sunflower oil)
Duration: four weeks Dosage: 5 drops/d
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants with constipation according to the Rome IV criteria.
* Signed informed consent by one of the child's parents or legal guardians
Exclusion Criteria
* 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.
6 Months
60 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Andrea Garcia Contreras
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrea Garcia Contreras
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edgar M Vásquez-Garibay, Doctor
Role: PRINCIPAL_INVESTIGATOR
full time staff member at the Division of Pediatrics of the New Civil Hospital of Guadalajara
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nuevo Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ojetti V, Ianiro G, Tortora A, D'Angelo G, Di Rienzo TA, Bibbo S, Migneco A, Gasbarrini A. The effect of Lactobacillus reuteri supplementation in adults with chronic functional constipation: a randomized, double-blind, placebo-controlled trial. J Gastrointestin Liver Dis. 2014 Dec;23(4):387-91. doi: 10.15403/jgld.2014.1121.234.elr.
Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.
Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. J Pediatr. 2010 Oct;157(4):598-602. doi: 10.1016/j.jpeds.2010.04.066. Epub 2010 Jun 12.
Choi CH, Chang SK. Alteration of gut microbiota and efficacy of probiotics in functional constipation. J Neurogastroenterol Motil. 2015 Jan 31;21(1):4-7. doi: 10.5056/jnm14142. No abstract available.
Attaluri A, Jackson M, Valestin J, Rao SS. Methanogenic flora is associated with altered colonic transit but not stool characteristics in constipation without IBS. Am J Gastroenterol. 2010 Jun;105(6):1407-11. doi: 10.1038/ajg.2009.655. Epub 2009 Dec 1.
Elawad MA, Sullivan PB. Management of constipation in children with disabilities. Dev Med Child Neurol. 2001 Dec;43(12):829-32. doi: 10.1017/s0012162201001505. No abstract available.
Tse PW, Leung SS, Chan T, Sien A, Chan AK. Dietary fibre intake and constipation in children with severe developmental disabilities. J Paediatr Child Health. 2000 Jun;36(3):236-9. doi: 10.1046/j.1440-1754.2000.00498.x.
Del Giudice E, Staiano A, Capano G, Romano A, Florimonte L, Miele E, Ciarla C, Campanozzi A, Crisanti AF. Gastrointestinal manifestations in children with cerebral palsy. Brain Dev. 1999 Jul;21(5):307-11. doi: 10.1016/s0387-7604(99)00025-x.
Park ES, Park CI, Cho SR, Na SI, Cho YS. Colonic transit time and constipation in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2004 Mar;85(3):453-6. doi: 10.1016/s0003-9993(03)00479-9.
Sullivan PB, Lambert B, Rose M, Ford-Adams M, Johnson A, Griffiths P. Prevalence and severity of feeding and nutritional problems in children with neurological impairment: Oxford Feeding Study. Dev Med Child Neurol. 2000 Oct;42(10):674-80. doi: 10.1017/s0012162200001249.
Morad M, Nelson NP, Merrick J, Davidson PW, Carmeli E. Prevalence and risk factors of constipation in adults with intellectual disability in residential care centers in Israel. Res Dev Disabil. 2007 Nov-Dec;28(6):580-6. doi: 10.1016/j.ridd.2006.08.002. Epub 2007 Mar 2.
Bohmer CJ, Taminiau JA, Klinkenberg-Knol EC, Meuwissen SG. The prevalence of constipation in institutionalized people with intellectual disability. J Intellect Disabil Res. 2001 Jun;45(Pt 3):212-8. doi: 10.1046/j.1365-2788.2001.00300.x.
Rosenbaum P. The natural history of gross motor development in children with cerebral palsy aged 1 to 15 years. Dev Med Child Neurol. 2007 Oct;49(10):724. doi: 10.1111/j.1469-8749.2007.00724.x. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0167/17
Identifier Type: -
Identifier Source: org_study_id