UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027302
Receipt number R000031284
Scientific Title Research on the effect of a lactic acid bacterium preparation for health conditions of females
Date of disclosure of the study information 2017/07/01
Last modified on 2021/05/18 09:58:11

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Basic information

Public title

Research on the effect of a lactic acid bacterium preparation for health conditions of females

Acronym

Research on the effect of a lactic acid bacterium preparation for health conditions of females

Scientific Title

Research on the effect of a lactic acid bacterium preparation for health conditions of females

Scientific Title:Acronym

Research on the effect of a lactic acid bacterium preparation for health conditions of females

Region

Japan


Condition

Condition

healthy adult females

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of the effects of LAB-ingestion on mental and physical conditions of females

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate the effects of LAB-ingestion on mental and physical conditions at 12 and 24 weeks after the start of intervention by questionnaires and related-measurement items

Key secondary outcomes

Autonomic nervous activity and abdominal symptom-related questionnaires and measurement items


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Daily intake of formulation including LAB for 24 weeks

Interventions/Control_2

Daily intake of placebo formulation without LAB for 24 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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Subjects are without major problems in psychological and physical health.

Key exclusion criteria

1. Subjects having history of psychiatric or somatic diseases in the past and present.
2. Subjects taking medication at least for three months prior to the enrollment and during the experimental period.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhito Rokutan

Organization

Tokushima University

Division name

Dept. of Pathophysiology, Inst. of Biomedical Sciences

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima

TEL

088-633-9004

Email

rokutan@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kensei Nishida

Organization

Tokushima University

Division name

Dept. of Pathophysiology, Inst. of Biomedical Sciences

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima

TEL

088-633-9004

Homepage URL


Email

knishida@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

Asahi Group Holdings, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 07 Month 01 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S175646462100075X

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S175646462100075X

Number of participants that the trial has enrolled

83

Results

Fifty-six women ingested CP2305 or placebo over the course of six menstrual cycles. The CP2305 group reported fewer psychological premenstrual symptoms. Water retention-related physical symptom scores were reduced in the placebo group. Significant differences were observed in the changes from baseline levels of salivary estradiol and progesterone between the two groups. CP2305 might improve the premenstrual symptoms of healthy young women in association with changes in reproductive hormone levels.

Results date posted

2021 Year 05 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The participant inclusion criteria were as follows: (i) females aged 20-35 years, (ii) provided signed informed consent and agreed to participate in this study. The exclusion criteria were as follows: (i) currently on medication, (ii) menstrual cycle is generally of atypical length (shorter than 25 days or longer than 38 days), (iii) diagnosed with a mental disorder or scored above 60 on the self-rating depression scale (SDS).

Participant flow

Eighty-three female students were recruited at Tokushima University (Tokushima, Japan). Written informed consent was obtained from each participant. Of the 83 subjects, 8 were excluded due to medication (n=3) and abnormal length of menstrual cycle (n=5). The remaining 75 subjects were randomly allocated to either the CP2305 (n=37) or placebo group (n=38) with a stratified randomization for age. We excluded 19 subjects who failed to continue daily tablet ingestion, complete questionnaires, or provide salivary samples, with no statistical difference in drop-out numbers between the two groups (placebo, n=7; CP2305, n=12; x2 test, p-value 0.5507). The reasons provided for discontinuing the trial were: (i) difficulty in taking tablets daily (placebo, n=3; CP2305, n=4), (ii) difficulty keeping a weekly diary (placebo, n=2; CP2305, n=4) and (iii) unknown (placebo, n=2; CP2305, n=4). The final sample population comprised 25 subjects in the CP2305 group and 31 in the placebo group.

Adverse events

No adverse events were observed in any of the subjects, including those that dropped out, throughout the course of the trial.

Outcome measures

The primary outcome was a change in the scale of the participants' psychological conditions during premenstrual period, which was evaluated using the PMTS-VAS questionnaire over time in the CP2305 group compared with the placebo group. The secondary outcomes were changes in the scale of the participants' physical conditions during the premenstrual period as assessed by an original VAS of luteal phase physical symptoms. In addition, changes in salivary hormone (cortisol, E2, and P4) and salivary chromogranin A (CgA) levels as the indicator for autonomic nervous activity, before and after administration in the CP2305 group, was compared to that of the placebo group.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 06 Month 15 Day

Date of IRB

2017 Year 06 Month 19 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 10 Day

Last modified on

2021 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031284


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name