Cerebral PalsyPhase 4NCT03117322
Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation
A Phase 4 study testing agave inulin, Lactobacillus reuteri DSM 17938 and maltodextrin in people with Cerebral Palsy and Chronic Constipation, run by Andrea Garcia Contreras at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Cerebral Palsy, Chronic Constipation
- What is being tested?
- agave inulin, Lactobacillus reuteri DSM 17938 and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 5 Jun 2017to 21 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Cerebral Palsy, Chronic Constipation
- Being tested
- agave inulin, Lactobacillus reuteri DSM 17938, maltodextrin, Oil mix (medium chain triglycerides and sunflower oil)
- Keywords
- cerebral palsy, children, chronic constipation, synbiotic, prebiotics, probiotics, agave inulin, microbiota
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agave inulinBiological
Duration: four weeks Dosage: powder 4 g/d
Lactobacillus reuteri DSM 17938Biological
Duration: four weeks Dosage: 5 drops/d
maltodextrinOther
Duration: four weeks Dosage: powder 4 g/d
Oil mix (medium chain triglycerides and sunflower oil)Other
Duration: four weeks Dosage: 5 drops/d
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: maltodextrin; Other: Oil mix (medium chain triglycerides and sunflower oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)
species/g
Measured: change from baseline bacteria composition at four weeks
change in consistency of feces
Bristol scale
Measured: change from baseline consistency at four weeks
change in potential of hydrogen (pH) of feces
pH scale
Measured: Change from baseline pH at four weeks
change in frequency of evacuations
evacuations per week
Measured: change from baseline frequency at four weeks
Secondary outcomes (1)
change in the concentration of short chain fatty acids in feces
millimoles (mM)
Measured: Change from baseline concentration at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start5 Jun 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Three interventions in parallel against a control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Garcia Contreras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Garcia Contreras, Hospital Civil Juan I. Menchaca
- Investigators
- Edgar M Vásquez-Garibay, Doctor, Principal investigator, full time staff member at the Division of Pediatrics of the New Civil Hospital of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117322
- Sponsor's protocol ID
- 0167/17
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25531996Indrio 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.
PubMed 24424513Coccorullo 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.
PubMed 20542295Choi 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.
PubMed 25611063Attaluri 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.
PubMed 19953090Elawad 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.
PubMed 11769270Tse 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.
PubMed 10849223Del 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.
PubMed 10413017Park 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.
PubMed 15031832Sullivan 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.
PubMed 11085295Morad 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.
PubMed 17336497Bohmer 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.
PubMed 11422645Rosenbaum 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.
PubMed 17880638
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03117322
- Acronym / sponsor ID
- 0167/17
- Conditions
- Cerebral Palsy, Chronic Constipation
- Keywords
- cerebral palsy, children, chronic constipation, synbiotic, prebiotics, probiotics, agave inulin, microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Andrea Garcia ContrerasUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Three interventions in parallel against a control group
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Biological: agave inulin, Biological: Lactobacillus reuteri DSM 17938Each 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. |
| Probiotic | Experimental | Biological: Lactobacillus reuteri DSM 17938, Other: maltodextrinLactobacillus reuteri DSM 17938 (1 x 10^8 cfu) in 5 drops and maltodextrin (4 g) in powder daily, once a day for four weeks. |
| Prebiotic | Experimental | Biological: agave inulin, Other: Oil mix (medium chain triglycerides and sunflower oil)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. |
| Placebo | Placebo comparator | Other: maltodextrin, Other: Oil mix (medium chain triglycerides and sunflower oil)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. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agave inulinDuration: four weeks Dosage: powder 4 g/d | Biological | Prebiotic, Synbiotic |
| Lactobacillus reuteri DSM 17938Duration: four weeks Dosage: 5 drops/d | Biological | Probiotic, Synbiotic |
| maltodextrinDuration: four weeks Dosage: powder 4 g/d | Other | Placebo, Probiotic |
| Oil mix (medium chain triglycerides and sunflower oil)Duration: four weeks Dosage: 5 drops/d | Other | Placebo, Prebiotic |
Primary outcome
Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)
Time frame: change from baseline bacteria composition at four weeks
species/g
change in consistency of feces
Time frame: change from baseline consistency at four weeks
Bristol scale
change in potential of hydrogen (pH) of feces
Time frame: Change from baseline pH at four weeks
pH scale
change in frequency of evacuations
Time frame: change from baseline frequency at four weeks
evacuations per week
1 secondary outcome
change in the concentration of short chain fatty acids in feces
Time frame: Change from baseline concentration at four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Background: PubMed 25531996Ojetti 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.
- Background: PubMed 24424513Indrio 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.
- Background: PubMed 20542295Coccorullo 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.
- Background: PubMed 25611063Choi 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.
- Background: PubMed 19953090Attaluri 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.
- Background: PubMed 11769270Elawad 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.
- Background: PubMed 10849223Tse 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.
- Background: PubMed 10413017Del 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.
- Background: PubMed 15031832Park 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.
- Background: PubMed 11085295Sullivan 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.
- Background: PubMed 17336497Morad 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.
- Background: PubMed 11422645Bohmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar M Vásquez-Garibay, Doctor principal investigator
full time staff member at the Division of Pediatrics of the New Civil Hospital of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing agave inulin, Lactobacillus reuteri DSM 17938 and maltodextrin in people with Cerebral Palsy and Chronic Constipation, run by Andrea Garcia Contreras at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli) (time frame: change from baseline bacteria composition at four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117322, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.