ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000350022

Ethics application status

Approved

Date submitted

9/03/2009

Date registered

3/05/2010

Date last updated

25/11/2019

Date data sharing statement initially provided

25/11/2019

Date results provided

25/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of Yakult on fermentation patterns and symptoms in irritable bowel syndrome

Scientific title

Randomised, placebo-controlled trial, followed by open-label treatment and withdrawal phases, of the effect of Yakult on fermentation patterns in patients with functional gut symptoms and an early rise of breath hydrogen after lactulose

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Irritable bowel syndrome

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Lactobacillus casei Shirota strain (Yakult)
65 ml once per day during the randomised placebo-controlled phase - duration 6 weeks
Upon completion, subjects will be offered 65 ml per day Yakult for 6 weeks.
During the withdrawal phase (6 weeks), no therapy is given (observation only)

Intervention code [1]

Treatment: Other

Comparator / control treatment

Placebo - identical to Yakult, except Lactobacillus is not added. Given 65 ml daily for 6 weeks (randomised controlled phase). No further placebo is used in the subsequent open-label and withdrawal phases.

Control group

Placebo

Outcomes

Primary outcome [1]

The proportion of patients altering the time of first rise of breath hydrogen after lactulose to greater than or equal to 75 minutes and/or delaying the rise by 30 minutes from baseline at week 6.
This is assessed by hydrogen breath testing following before and every 15 minutes for 2-3 hours after the ingestion of 15 g lactulose.

Timepoint [1]

week 6

Secondary outcome [1]

Double-blind phase: the change in time of the first rise in breath hydrogen after lactulose.
This is assessed by hydrogen breath testing following before and every 15 minutes for 2-3 hoursafter the ingestion of 15 g lactulose.

Timepoint [1]

Week 6

Secondary outcome [2]

Double-blind phase: Proportion of patients altering status of fructose breath test from that prior to entering the study.
This is assessed by hydrogen breath testing following before and every 20 minutes after the ingestion of 35 g lactulose.

Timepoint [2]

Week 6

Secondary outcome [3]

double-blind phase: The change in gastric emptying time.
This is measured using C-13 acetic acid liquid gastric emptying by assessing breath C-13 every 15 minutes over 240 minutes via the Iris infrared isotope analyser and associated software. It is performed concurrently with the lactulose breath hydrogen test. 100 mg C-13 sodium acetate is added to the lactulose solution

Timepoint [3]

week 6

Secondary outcome [4]

double-blind phase: The change in visual analogue (VAS) scores for overall and specific gut symptoms for Yakult-treated vs placebo-treated patients,

Timepoint [4]

week 6

Secondary outcome [5]

The change in visual analogue (VAS) scores for overall and specific gut symptoms for those correcting early rise in breath hydrogen after lactulose (ERBHAL) vs those with continuing ERBHAL

Timepoint [5]

week 12

Secondary outcome [6]

The change in visual analogue (VAS) scores for overall and specific gut symptoms for those correcting early rise in breath hydrogen after lactulose (ERBHAL) vs those with continuing ERBHAL

Timepoint [6]

week 18

Secondary outcome [7]

Adverse events.
These will be assessed by diary entries and by direct questioning at 3 weekly visits for 18 weeks of the study; i.e., assessed by history taking and physical examination. Expected adverse events will be exacerbation of irritable bowel syndrome, nausea, and trivial events unrelated to the study medication

Timepoint [7]

up to 18 weeks

Secondary outcome [8]

Timepoint [8]

Week 12 and week 18

Secondary outcome [9]

double-blind phase: The change in visual analogue (VAS) scores for overall and specific gut symptoms for those correcting early rise in breath hydrogen after lactulose (ERBHAL) vs those with continuing ERBHAL

Timepoint [9]

week 6

Eligibility

Key inclusion criteria

1. ERBHAL, defined as a rise of breath hydrogen of 10 ppm or greater above baseline breath hydrogen on two consecutive 15-minute samples before 90 minutes following ingestion of lactulose;
2. Irritable bowel syndrome according to Rome III criteria;
3. On no specific medication for irritable bowel syndrome
4. On a stable diet for the four weeks prior to entering the study and during the study;
5. Able to maintain current drug therapy for functional gut symptoms without change in drugs or dose during the study;
6. Able to give written, informed consent

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. treatment for greater than two weeks with any probiotic within the previous 3 months;
2. any antibiotic therapy in the previous two months;
3. excessive alcohol intake
4. clinically significant co-morbidity

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subjects identified by study staff. Allocation of treatment determined by schedule off-site

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomization table created by a computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2010

Actual

3/08/2010

Date of last participant enrolment

Anticipated

Actual

6/06/2012

Date of last data collection

Anticipated

Actual

13/11/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Yakult Australia Pt Ltd

Address [1]

10 Monterey Road
Dandenong Vic 3175

Country [1]

Australia

Primary sponsor type

Hospital

Name

Box Hill Hospital

Address

5 Arnold Street,
Box Hill
Vic 3128

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Monash University

Address [1]

Box Hill hospital
5 Arnold Street
Box Hill
Vic 3128

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Research & Ethics Committee

Ethics committee address [1]

Box Hill Hospital
5 Arnold Street
Box Hill 
Vic 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/02/2009

Ethics approval number [1]

E61/0809

Summary

Brief summary

Current therapy for irritable bowel syndrome is suboptimal. Recent studies have suggested that small intestinal bacterial overgrowth may be present and that its treatment may have therapeutic benefit. The primary aim is to examine whether the effect of Yakult on a breath hydrogen test feature of bacterial overgorwoth that was seen in the pilot study is reproducible and specific to the study treatment, or just a chance observation. The secondary aims were to define the effect of Yakult on the rate at which the stomach empties, to compare the effects on gut symptoms of Yakult, placebo and Yakult withdrawal, and to examine the association of change in breath test patterns with changes in gut symptoms. In addition, because bacterial overgrowth is said to be causally associated with fructose malabsorption, another aim is to examine the effect of Yakult and the changes in breath test patterns with changes in fructose absorption and malabsorption.
The major study hypotheses are that Yakult corrects small intestinal bacterial overgrowth and that this correction is associated with improvement in symptoms of irritable bowel syndrome

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peter Gibson

Address

Monash University / The Alfred Hospital
Department of Gastroenterology
Central Clinical School
Level 6, 99 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+613 9076 2223

Fax

peter.gibson@monash.edu

Contact person for public queries

Name

CK Yao

Address

Department of Medicine
Box Hill Hospital
Box Hill Vic 3128

Country

Australia

Phone

+61 3 9094 9547

Fax

+61 3 9899 9137

jacqueline.barrett@med.monash.edu.au

Contact person for scientific queries

Name

CK Yao

Address

Department of Gastroenterology
Central Clinical School
Monash University & The Alfred Hospital
Melbourne VIC 3004

Country

Australia

Phone

+613 99030266

Fax

+61 3 9899 9137

chu.yao@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Poor predictive value of breath hydrogen response for probiotic effects in IBS.	2015	https://dx.doi.org/10.1111/jgh.13015

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically