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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034508
Receipt No. R000039341
Scientific Title Examination of the diet cure for the pediatric constipation - assessment of the dietary fiber intake and the cow's milk allergy -
Date of disclosure of the study information 2018/10/16
Last modified on 2019/04/20

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Basic information
Public title Examination of the diet cure for the pediatric constipation - assessment of the dietary fiber intake and the cow's milk allergy -
Acronym Examination of the diet cure for the pediatric constipation
Scientific Title Examination of the diet cure for the pediatric constipation - assessment of the dietary fiber intake and the cow's milk allergy -
Scientific Title:Acronym Examination of the diet cure for the pediatric constipation
Region
Japan

Condition
Condition Chronic constipation
Classification by specialty
Gastroenterology Gastrointestinal surgery Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of the dietary fiber load and the cow's-milk-free diet for pediatric patients with chronic constipation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation frequency without enema
Key secondary outcomes Bristol stool scale
Madication
Enema use frequency
Dietary intake state
Fecal microbiota

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Group A: Observation 4 week. Dietary fiber load 4 week. Dietary fiber load + Cow's milk free diet 4 week.
Interventions/Control_2 Group B: Observation 4 week. Dietary fiber load + Cow's milk free diet 4 week. Dietary fiber load 4 week.
Interventions/Control_3
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
1 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with chronic constipation who satisfy the Rome3 criteria
2) Written informed consent provided for study participation
Key exclusion criteria 1) Gastroenterological surgical disease before radical operation
2) Food allergy
3) Neurological impaired patients
4) Epilepsy
5) Users of Histamine H1 receptor antagonist
6) Gastroenteritis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shinya
Middle name
Last name Takazawa
Organization Gunma children's medical center
Division name Department of pediatric surgery
Zip code 377-8577
Address 779 Shimohakoda, Hokkitsu, Shibukawa, Gunma 377-8577, JAPAN
TEL +81-279-52-3551
Email shinya.takazawa@gmail.com

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Isoda
Organization Gunma children's medical center
Division name Nutrition and food preparation division
Zip code 377-8577
Address 779 Shimohakoda, Hokkitsu, Shibukawa, Gunma 377-8577, JAPAN
TEL +81-279-52-3551
Homepage URL
Email eiyou@gcmc.pref.gunma.jp

Sponsor
Institute Gunma children's medical center
Institute
Department

Funding Source
Organization Gunma prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical Committee of Gunma children's medical center
Address 779 Shimohakoda, Hokkitsu, Shibukawa, Gunma 377-8577, JAPAN
Tel +81-279-52-3551
Email sino-m@pref.gunma.lg.jp

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 10 Month 16 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 04 Day
Date of IRB
2018 Year 10 Month 03 Day
Anticipated trial start date
2018 Year 10 Month 16 Day
Last follow-up date
2020 Year 03 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 10 Month 15 Day
Last modified on
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039341

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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