UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023298 |
|---|---|
| Receipt number | R000026742 |
| Scientific Title | Evaluation of the treatment efficacy by incrementally increasing dosage of cow's milk on patients with lactose intolerance |
| Date of disclosure of the study information | 2016/07/22 |
| Last modified on | 2020/05/25 16:43:05 |
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Basic information
Public title
Evaluation of the treatment efficacy by incrementally increasing dosage of cow's milk on patients with lactose intolerance
Acronym
The lactose intolerance treatment by incrementally increasing dosage of cow's milk
Scientific Title
Evaluation of the treatment efficacy by incrementally increasing dosage of cow's milk on patients with lactose intolerance
Scientific Title:Acronym
The lactose intolerance treatment by incrementally increasing dosage of cow's milk
Region
| Japan |
Condition
Condition
Lactose Intolerance
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients who complain of abdominal symptoms due to cow's milk consumption are screened to make sure that there are no clinical symptoms induced by consumption of cow's milk with reduced lactose (excluding psychogenic causes), followed by starting small dosage of general cow's milk with lactose of which amount is incrementally increased (incremental increase of lactose load) on daily basis in order to investigate the improved lactose absorption capacity and the reduced clinical symptoms (acquirement of lactose tolerance). Moreover, changes in intestinal bacterial flora, as well as its roles, are evaluated among before and after the treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in severity of abdominal symptoms before and after the treatment (8 weeks maximum) by continuing incremental increase of cow's milk load for certain period.
Key secondary outcomes
1.Ratio of abdominal symptoms (such as psychogenic causes) in single blind comparative study on cow's milk and lactose-reduced milk
2.Ratio of true lactose intolerance from the result of lactose tolerance test
3.Changes in before and after the treatment listed below
Lactose tolerance test and intestinal bacterial flora
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
After screening by questionnaire survey and agreement to informed consent for the patients with abdominal symptoms due to diary consumption, a single blind comparative study is conducted by observing the abdominal symptoms after dosage of 200ml of lactose-reduced milk and general cow's milk with an interval of 1 week or longer.
Eligible patients with abdominal symptoms only due to cow's milk from the above study have lactose tolerance test and be taken their stool samples prior to the following treatment for lactose tolerance acquirement.
Treatment for lactose tolerance acquirement
The treatment on eligible patients with cow's milk (lactose) intolerance from definitive diagnosis starts with small dosage (30ml) of cow's milk around the same time each day on an empty stomach. If there was no abdominal symptom, the dosage is increased by 30ml with 4 days interval. If the symptoms presented, the same amount is kept for up to 7 days. The study continues up to 8 weeks until the dosage increases to 200ml or more. The daily record of the symptoms is given by each patient during the treatment period.
At the end of the treatment for lactose tolerance acquirement, lactose tolerance test is performed and stool samples are taken on the subjects.
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Out-patients in the department of pediatrics, Tokyo Wemens Medical University, Medical Center East and study subjects recruited from collaborative institutes
2.Patients with abdominal symptoms due to cow's milk consumption
Key exclusion criteria
1.Patients with cow's milk allergy
2.Patients with Chronic digestive diseases, hematologic diseases, endocrine/metabolic diseases, and psycho-neurologic diseases
3.Pregnant or expected female patients
4.Other patients that the research director considers to be unsuitable in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigetaka |
| Middle name | |
| Last name | Sugihara |
Organization
Tokyo Women's Medical University,Medical Center East
Division name
the department of pediatrics
Zip code
116-8567
Address
2-1-10 Nishiogu, arakawa-ku, Tokyo
TEL
03-3810-1111
sghrsgpd@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Okada |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
the department of pediatrics
Zip code
116-8567
Address
2-1-10 Nishiogu, arakawa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
k.okada-med@nifty.com
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East
Institute
Department
Personal name
Funding Source
Organization
Japan Dairy Association (J-milk)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Jumonji University
Nihon University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Ethics Committee
Address
8-1 Kawada-cho, shinjuku-ku, Tokyo
Tel
03-3353-8111
krinri.bm@twmu.ac.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
東京女子医科大学東医療センター Tokyo Wemens Medical University, Medical Center East
小児科（東京都）Department of Pediatrics (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
47
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 22 | 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
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026742
