UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018422 |
|---|---|
| Receipt number | R000021326 |
| Scientific Title | Research of increased gas by lactulose load test in irritable bowel syndrome |
| Date of disclosure of the study information | 2015/07/25 |
| Last modified on | 2016/03/07 10:44:36 |
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Basic information
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
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
Objectives
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
Assessment
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.
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
yoshiharu333@hotmail.com
Public contact
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
yoshiharu333@hotmail.com
Sponsor or person
Institute
Office Uno column
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
http://dx.doi.org/10.4236/ojgas.2015.511025
Publication of results
Unpublished
Result
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
Progress
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
Other related information
Management 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
