UMIN-CTR Clinical Trial

Public title

Research of increased gas by lactulose load test in irritable bowel syndrome

Acronym

Lactulose test for IBS and SIBO

Scientific Title

Research of increased gas by lactulose load test in irritable bowel syndrome

Scientific Title:Acronym

Lactulose test for IBS and SIBO

Region

Japan

Condition

irritable bowel syndrome, small intestinal bacterial overgrowth

Classification by specialty

Medicine in general	Gastroenterology	Psychosomatic Internal Medicine
Adult	Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1) Fermentation site and increasing time of symptomatic gas would be different between IBS and SIBO. Differential diagnosis of IBS and SIBO has been mainly carried out in the lactulose breath test. However, after load of lactulose, it has not been verified whether how much gas is present. Also, it not been confirmed that has increased at small intestine in SIBO patients. The amount of lactulose load is 10g in a breath test. However, in report of a high FODMAP diet, the gas increases was needed 16g at one meal, and gases began to increased after 4-5 hours.The aim of this study was to determine the time for increase in abdominal gas following ingestion of lactulose and the possibility of differential diagnosis of SIBO and IBS. To evaluate the effective dose of lactulose, lactulose is given either 10 g or 13 g per weight 50 kg. (Pilot study)
2) Defines the method of self-diagnosis of IBS and SIBO by lactulose.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Imaging is first performed in early morning after fasting. After ingestion of lactulose, 1-4 plain abdominal radiographs are taken for investigation of increased gas during the indicated timeframe. Regions of interest of the gas areas are highlighted on the images obtained. Gas images were divided into three areas, the stomach, small intestine, and large intestine, and each total area is calculated.

Key secondary outcomes

It is investigated the relationship between the symptoms and the gas of the amount which appears after lactulose load. By that relationship, it will determine whether it is possible to diagnosis of IBS and SIBO only a symptom of post-lactulose load.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

The first group; lactulose 10g / 50kg load after 30 minutes to 120 minutes of observation.

Interventions/Control_2

The second group; lactulose 13g / 50kg 240 minutes to 300 minutes of observation after load.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

According to the Rome III criteria of IBS.

Key exclusion criteria

Person who suffering from organic diseases. (When disease is not healed).

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiharu Uno

Organization

Oroku Hospital

Division name

Unit of Gastroentelorogy

Zip code

Address

Oroku-547-1, Naha, Okinawa

TEL

098-857-1789

Email

yoshiharu333@hotmail.com

Name of contact person

1st name
Middle name
Last name	Yoshiharu Uno

Organization

Office Uno Column

Division name

Editor

Zip code

Address

Yota 419-2, Onoe-cho, Kakogawa, Hyogo

TEL

09069923113

Homepage URL

Email

yoshiharu333@hotmail.com

Institute

Office Uno column

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

07

Month

25

Day

URL releasing protocol

http://dx.doi.org/10.4236/ojgas.2015.511025

Publication of results

Unpublished

URL related to results and publications

http://dx.doi.org/10.4236/ojgas.2015.511025

Number of participants that the trial has enrolled

Results

At a dose of 10 g lactulose and an observation time of two hours, patients displayed no symptoms, and the gas volume was only slightly increased. However, when the dose of lactulose was increased (13 g/50 kg), and the observation time for the lactulose challenge was extended to 240-300 minutes, the results clearly demonstrated an increase in the gas produced in IBS patients.

Open Journal of Gastroenterology, 2015, 5, 155-163

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

05

Month

07

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

26

Day

Last follow-up date

2015

Year

12

Month

30

Day

Date of closure to data entry

2015

Year

12

Month

30

Day

Date trial data considered complete

2015

Year

12

Month

30

Day

Date analysis concluded

2015

Year

12

Month

30

Day

Other related information

Registered date

2015

Year

07

Month

25

Day

Last modified on

2016

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021326