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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033922
Receipt No. R000038678
Scientific Title Effect of Lactobacillus reuteri DSM 17938 in Infants with Functional Chronic Constipation and the Change of Intestinal Microbiome
Date of disclosure of the study information 2018/08/31
Last modified on 2018/08/27

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Basic information
Public title Effect of Lactobacillus reuteri DSM 17938 in Infants with Functional Chronic Constipation and the Change of Intestinal Microbiome
Acronym Effect of Lacctobacillus reuteri DSM 17938 on functional constipation of infants
Scientific Title Effect of Lactobacillus reuteri DSM 17938 in Infants with Functional Chronic Constipation and the Change of Intestinal Microbiome
Scientific Title:Acronym Effect of Lacctobacillus reuteri DSM 17938 on functional constipation of infants
Region
Japan

Condition
Condition Functional Chronic Constipation
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effects of Lacctobacillus reuteri DSM 17938 and magnesium oxide on pediatric functional chronic constipation patients and the change in the intestinal microbiota and develop theraputic strategies that are safe and optimal for these patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of defecation
Key secondary outcomes Status of defication, pain during defecation, bleeding during defecation, fecal microbiome

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Group A: L.reuteri 5drops x 2/day and Placebo of MO x 2/day x 4 weeks
Interventions/Control_2 Group B: L.reuteri 5drops x 2/day and MO x 2/day x 4 weeks
Interventions/Control_3 Group C:Placebo of L.reuteri 5drops x 2/day and MO x 2/day x 4 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
6 months-old <
Age-upper limit
72 months-old >
Gender Male and Female
Key inclusion criteria 1)Person who clears Rome IV criteria
At least 2 or more have continued for 1 month or more from the following symptoms
Defecation less than twice a week
History of excessive stool retention
Painful bowel movements
Giant fecal lump in the rectum
Huge stool history
Following establishment of toilet habits the following criteria will also be added
At least feces incontinence at least once a week (after defecation in the toilet)
A huge chaotic mass that the toilet is clogged

2)The age must be 6 months or more and less than 6 years old
3)Being after the start of weaning food



Key exclusion criteria Exclude those with underlying diseases that can cause constipation. (Hirschsprung disease,
Spina bifida, milk allergy etc.)
Magnesium oxide preparations exclude diseases that may cause hypermagnesemia
(Such as kidney disease)
Infants under 6 months, children over 6 years old
Infants who have not started baby food



Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Kubota
Organization Kubota Children's Clinic
Division name Pediatrics
Zip code
Address 2-6-18 Kitakatsuyama Ikunoku Osaka
TEL 06-7894-1100
Email meg@ki.rim.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Kubota
Organization Kubota children's clinic
Division name pediatrics
Zip code
Address 2-6-18 Kitakatsuyama Ikunoku Osaka
TEL 06-7894-1100
Homepage URL http://www.kubota-kids.com/
Email meg@ki.rim.or.jp

Sponsor
Institute Kubota children's clinic
Institute
Department

Funding Source
Organization Biogaia AB
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Sweden

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 27 Day
Last modified on
2018 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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