UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000033922
Receipt number	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	2022/10/20 12:09:40

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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

Functional Chronic Constipation

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

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

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

Research contact person

Name of lead principal investigator

1st name Megumi

Middle name

Last name Kubota

Organization

Kubota Children's Clinic

Division name

Pediatrics

Zip code

5440033

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 Megumi

Middle name

Last name Megumi Kubota

Organization

Kubota children's clinic

Division name

pediatrics

Zip code

5440033

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 or person

Institute

Kubota children's clinic

Institute

Department

Personal name

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

Kubota children's clinic

Address

2-6-18 Katsuyamakita Ikunoku Osaka

Tel

0678941100

Email

kub.chil2618@gmail.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 31 Day

Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019518/

Publication of results

Published

Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019518/

Number of participants that the trial has enrolled

Results

L. rueteri DSM 17938 and MgO were both effective in the management of functional constipation in young children. MgO caused an imbalance in the gastrointestinal microbiome, which was not the case in the probiotic group.

Results date posted

2022 Year 10 Month 20 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Sixty-three patients were recruited to this study and randomly assigned to groups. Three were excluded (two for using antibiotics for otitis media and one that developed Kawasaki disease during study period), so a total of 60 patients enrolled. There were no marked differences between the three groups with respect to gender, age, and baseline condition

Participant flow

Sixty patients were randomly divided into three groups according to an automatically generated randomization list: group A (n = 20) received L. rueteri DSM 17938 and lactose hydrate as a placebo of MgO; group B (n = 19) received L. rueteri DSM 17938 and MgO and lactose hydrate; and group C (n = 21) received a placebo of L. rueteri DSM 17938 and MgO and lactose hydrate.

Adverse events

No adverse event related to any treatment was observed in this study.

Outcome measures

All three groups exhibited significant improvement in defecation frequency in the fourth week compared with the baseline condition (group A: p < 0.05; group B: p < 0.05; group C: p < 0.05). The MgO group and combination group showed a significant decrease in stool consistency, but the L. reuteri DSM 17938 group did not (group A: p = 0.079; group B: p < 0.05; group C: p < 0.05). MgO significantly suppressed the presence of the genus Dialister. Defecation frequency negatively correlated with the frequency of Clostridiales-belonging bacteria among the gut microbiome. Conclusions: L. rueteri DSM 17938 and MgO were both effective in the management of functional constipation in young children. MgO caused an imbalance in the gastrointestinal microbiome, which was not the case in the probiotic group.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 01 Day

Date of IRB

2016 Year 12 Month 01 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

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

2022 Year 10 Month 20 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038678

Research Plan
Registered date	File name
2020/08/28	12_shinseisyo (final).docx

Research case data specifications
Registered date	File name
2020/08/28	便秘スコア計算表(VER2).xlsx

Research case data
Registered date	File name