UMIN-CTR Clinical Trial

Public title

Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation

Acronym

Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation

Scientific Title

Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation

Scientific Title:Acronym

Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation

Region

Japan

Condition

Chronic Constipation

Classification by specialty

Gastroenterology

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the efficacy of Bifidobacterium longum BB536 for chronic constipation

To analyze the change of intestinal microbiota for eldary patients by intake of probiotics

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

constipation scoring system(CSS)

Key secondary outcomes

Bristol Stool Scale (BSS)
FSSG(frequency scale for the symptoms of GERD)
Izumo scale
intestinal bacterial flora

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Investigational Treatment: Bifidobacterium longum BB536 o.d. p.o. 4 weeks

Interventions/Control_2

Comparative treatment: Placebo o.d.
p.o. 4 weeks

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

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Age 65 or older

2)Patients with chronic constipation who satisfy the clinical criteria :
a)Functional constipation or Constipation-predominant irritable bowel syndrome diagnosed by Rome4
b)constipation scoring system: 6 or more

3)Written informed consent provided
for study participation

Key exclusion criteria

1)Parkinson's disease, multiple sclerosis, cerebral infection, spinal cord lesion

2)uncontrolled Diabetes mellitus, Hypothyroidism, Uremia

3)Users of Opioid, Anticholinergics, Anticonvulsants, Antiemetics

4)Amyloidosis, systemic sclerosis, heavy metal poisoning

5)Severe disease(cerebro-vascular, he
art, liver, renal , gastro-intestinal, end
ocrine-metabolic, infectious disease).
Cancer of the alimentary system. After
gastrointestinal tract resection. Inflam
matory bowel disease(IBD).

6)Users of antibiotic, medicine for intestinal disorders, irritative laxative, antidiarrheic and health food, supplement (lactic acid bacterium, bifidus bacillus, oligosaccharide,dietary fiber)

7) Remarkable abnormality for blood p
ressure, blood test. Severe anemia. All
ergy for drug and food. Heavy smoker,
drinker. Irregular lifestyle such as a m
eal, the sleep.

8) Considered by the principal investig
ator to be ineligible.

Target sample size

80

Name of lead principal investigator

1st name	Tsutomu
Middle name
Last name	Takeda

Organization

Juntendo Tokyo Koto Geriatric Medical
Center

Division name

Department of Gastroenterology

Zip code

136-0075

Address

3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan

TEL

+81-3-5632-3111

Email

t-takeda@juntendo.ac.jp

Name of contact person

1st name	Tsutomu
Middle name
Last name	Takeda

Organization

Juntendo Tokyo Koto Geriatric Medical Center

Division name

Department of Gastroenterology

Zip code

136-0075

Address

3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan

TEL

+81-3-5632-3111

Homepage URL

Email

t-takeda@juntendo.ac.jp

Institute

Juntendo Tokyo Koto Geriatric Medical Center
Department of Gastroenterology

Institute

Department

Personal name

Organization

University of Juntendo, intestinal flora
research course

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Juntendo Tokyo Koto Geriatric Medical Center Institutional Review Board

Address

3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan

Tel

+81-3-5632-3111

Email

nakano_takahiko@juntendo.gmc.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂東京江東高齢者医療センター（東京都）

Date of disclosure of the study information

2018

Year

06

Month

18

Day

URL releasing protocol

https://journals.lww.com/ajg/fulltext/2023/03000/usefulness_of_bifidobacterium_longum_bb536_in.37.as

Publication of results

Published

URL related to results and publications

https://journals.lww.com/ajg/fulltext/2023/03000/usefulness_of_bifidobacterium_longum_bb536_in.37.as

Number of participants that the trial has enrolled

80

Results

A total of 79 patients (mean age:77.9 y), including 38 patients in the BB536 group and 41 in the placebo group, completed the study. The primary end point was not significant (P=0.074), although there was significant improvement (P<0.01) in the BB536 group from baseline to week 4, but there were no significant changes in the placebo group. There was a significant difference and a tendency toward a difference in the changes from baseline on the stool frequency (P=0.008) and failure of evacuation (P=0.051).

Results date posted

2023

Year

10

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Ninety-six patients were evaluated for eligibility, and 80 were randomly assigned. There were 80 patients (M/F: 36/44, mean age 77.9 years), including 39 patients in the probiotic group and 41 in the placebo group, and there were no differences in the patient backgrounds between the groups.

Participant flow

One patient in the probiotic group dropped out because of difficulty in going to the hospital, which left 38 patients in the probiotic group and 41 patients in the placebo group who were evaluated. After the assessment for eligibility, randomization was conducted using random permuted blocks of the participants after they were stratified by sex (male vs female) and CSS score (>9 vs <9) to ensure a balanced allocation of the participants in the probiotic (BB536) and placebo groups. Sachets containing lyophilized powder of B. longum BB536 (5 x 1010 colony-forming unit or more, 2 g/package) or placebo were prepared as previously described. Each participant consumed 1 probiotic or placebo sachet daily for 4 weeks and was asked to participate in 4 weeks of postobservation. The patients were assessed by 2 questionnaires: the CSS and frequency scale for the symptoms of gastrointestinal reflux disease (FSSG; gastrointestinal reflux disease). Fecal samples were collected before and after the intervention. The fecal DNA preparation and microbiota analysis were performed.

Adverse events

No deaths occurred in the trial. One case of diarrhea was observed during treatment intake in both the BB536 and placebo groups. There were no differences in the incidence of serious, total adverse events, or withdrawals due to adverse events between the BB536 and placebo groups. There were no adverse events secondary to the administration of the treatment.

Outcome measures

The total CSS after intervention (week 4) was the primary end point, and the FSSG total score and the subscale scores of CSS and GERD as well as the changed scores from baseline were the secondary end points.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2017

Year

11

Month

24

Day

Date of IRB

2017

Year

11

Month

24

Day

Anticipated trial start date

2018

Year

06

Month

18

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

2020

Year

10

Month

16

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

18

Day

Last modified on

2023

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037498