UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034508 |
|---|---|
| Receipt number | 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 | 2022/10/26 07:49:09 |
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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
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
shinya.takazawa@gmail.com
Sponsor or person
Institute
Gunma children's medical center
Institute
Department
Personal name
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
takao-su@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
https://www.pref.gunma.jp/contents/100201634.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.pref.gunma.jp/contents/100201634.pdf
Number of participants that the trial has enrolled
11
Results
Average dietary fiber intake was significantly increased during the dietary fiber period compared to the observation period.
The average number of self-defecations per day increased during the milk removal period.
The number of enemas was reduced by diet.
A stool test was performed on 5 cases, and butyric acid and propionic acid, which are thought to cause peristalsis of the large intestine after nutritional guidance, tended to increase in the milk-removed group.
Results date posted
| 2022 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven patients participated and the average age was 5.3 years. Of these, 4 were children after surgery.
Participant flow
Eleven patients participated, three withdrew, and eight completed the protocol.
Adverse events
No adverse events due to dietary guidance were observed.
Outcome measures
Average dietary fiber intake was significantly increased during the dietary fiber period compared to the observation period.
The average number of self-defecations per day increased during the milk removal period.
The number of enemas was reduced by diet.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer 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
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039341
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