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

NCT03117322 | Completed Phase 4

• 1 other identifier: 0167/17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Chronic Constipation

Keywords

cerebral palsy; children; chronic constipation; synbiotic; prebiotics; probiotics; agave inulin; microbiota

Outcome Measures

Primary Outcomes (4)

• Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)

  species/g

  change from baseline bacteria composition at four weeks

• change in consistency of feces

  Bristol scale

  change from baseline consistency at four weeks

• change in potential of hydrogen (pH) of feces

  pH scale

  Change from baseline pH at four weeks

• change in frequency of evacuations

  evacuations per week

  change from baseline frequency at four weeks

Secondary Outcomes (1)

• change in the concentration of short chain fatty acids in feces

  Change from baseline concentration at four weeks

Other Outcomes (4)

• Change in Body weight

  Change from baseline weight at four weeks

• length

  Baseline

• Change of Dietary fiber intake

  Change from baseline dietary fiber intake at four weeks

Study Arms (4)

Synbiotic

EXPERIMENTAL

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; Biological: Lactobacillus reuteri DSM 17938

Probiotic

EXPERIMENTAL

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; Other: maltodextrin

Prebiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

agave inulin BIOLOGICAL

Duration: four weeks Dosage: powder 4 g/d

Prebiotic; Synbiotic

Lactobacillus reuteri DSM 17938 BIOLOGICAL

Duration: four weeks Dosage: 5 drops/d

Probiotic; Synbiotic

maltodextrin OTHER

Duration: four weeks Dosage: powder 4 g/d

Placebo; Probiotic

Oil mix (medium chain triglycerides and sunflower oil) OTHER

Duration: four weeks Dosage: 5 drops/d

Placebo; Prebiotic

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrea Garcia Contreras: lead

Study Sites (1)

Nuevo Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (13)

• 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.

  PMID: 25531996 BACKGROUND

• 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.

  PMID: 24424513 BACKGROUND

• 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.

  PMID: 20542295 BACKGROUND

• 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.

  PMID: 25611063 BACKGROUND

• 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.

  PMID: 19953090 BACKGROUND

• 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.

  PMID: 11769270 BACKGROUND

• 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.

  PMID: 10849223 BACKGROUND

• 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.

  PMID: 10413017 BACKGROUND

• 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.

  PMID: 15031832 BACKGROUND

• 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.

  PMID: 11085295 BACKGROUND

• 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.

  PMID: 17336497 BACKGROUND

• 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.

  PMID: 11422645 BACKGROUND

• 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.

  PMID: 17880638 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

maltodextrin; Sunflower Oil

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Edgar M Vásquez-Garibay, Doctor

  full time staff member at the Division of Pediatrics of the New Civil Hospital of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: pediatric neurologist and laboratory staff.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Three interventions in parallel against a control group

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 17, 2017
• Study Start: June 5, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)