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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026742


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name