UMIN-CTR Clinical Trial

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
Email	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
Email	k.okada-med@nifty.com

Sponsor
Institute	Tokyo Women's Medical University Medical Center East
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026742