UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048875 |
|---|---|
| Receipt number | R000055669 |
| Scientific Title | Study on the effect of foods containing inanimate lactic acid bacterium LJ88 on temporary stomach symptoms in adults: Placebo-controlled, randomized, double-blind, parallel-group comparison method |
| Date of disclosure of the study information | 2022/09/09 |
| Last modified on | 2024/04/26 13:34:55 |
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Basic information
Public title
Study on the effect of foods containing inanimate lactic acid bacterium LJ88 on temporary stomach symptoms
Acronym
Effects of lactic acid bacterium LJ88 on the stomach
Scientific Title
Study on the effect of foods containing inanimate lactic acid bacterium LJ88 on temporary stomach symptoms in adults: Placebo-controlled, randomized, double-blind, parallel-group comparison method
Scientific Title:Acronym
Effects of lactic acid bacterium LJ88 on the stomach: an RCT study
Region
| Japan |
Condition
Condition
Stomach symptoms (non-diseased state)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of foods containing inanimate lactic acid bacterium LJ88 in healthy adults on the efficacy on temporary stomach symptoms and the safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency scale for the symptoms of GERD (FSSG) score after 6 weeks ingestion
Key secondary outcomes
(1) GSRS
(2) Stomach symptom questionnaire (comprehensive impression score by research subjects)
(3) POMS2 shortened version
(4) SF-36v2 Japanese version: Acute version
(5) Serum gastrin concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of food containing inanimate lactic acid bacterium LJ88 about 1 billion cells (6 weeks)
Interventions/Control_2
Oral ingestion of Placebo food (6 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged between 20 and 64 on the date of obtaining consent
(2) Those who have a FSSG score of 8 points or more
(3) Those who have received a sufficient explanation of the purpose and contents of the research, have the ability to consent, and who have fully understood and voluntarily applied to participate in this research, and consented to participate in this research in writing.
Key exclusion criteria
(1) Those who have a history of Helicobacter pylori infection, or those who are positive for H. pylori antibodies (blood anti-H. pylori antibodies)
(2) Those who regularly use drugs that affect stomach symptoms
(3) Those who are diagnosed with functional dyspepsia according to the ROME IV criteria (specifically, those who have had upper abdominal symptoms that "feel painful" for more than 6 months and have had the above symptoms for the past 3 months)
(4) Those who cannot restrict intake of probiotic foods, prebiotic foods, foods containing lactic acid bacteria and bifidobacteria, and other health foods that are effective in improving gastric symptoms during the study period.
(5) Those who have current medical conditions such as organic diseases of the stomach (gastric ulcer, gastric cancer, gastritis, gastroesophageal reflux disease, etc.)
(6) Those who have experienced food allergies
(7) Those who have frequently become aware of not feeling well due to intake of dairy products.
(8) Those who have a disease requiring urgent treatment or who have serious complications
(9) Those with gastrointestinal diseases that affect digestion and absorption or defecation, or those with a history of surgery
(10) Those who are judged to be unsuitable as research subjects based on the blood test performed in the screening test
(11) Pregnant, intending to become pregnant during the research period, or breast-feeding
(12) Those who are with a history of drug dependence or alcohol dependence or current illness
(13) Those who are participating in research that uses other foods or drugs, or that apply cosmetics or drugs, or those who intend to participate
(14) Others who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo bldg. 201, 13-4 Kodenma-cho, Nihonbashi, Chuo-ku, Tokyo 103-0001, Japan
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Komatsu |
Organization
Snowden Co., Ltd.
Division name
R&D, Merchandising Div.
Zip code
101-0032
Address
3-7-6 Iwamoto-cho, Chiyoda-ku, Tokyo 101-0032, Japan
TEL
03-3866-2828
Homepage URL
y_komatsu@snowden.co.jp
Sponsor or person
Institute
Nihonbashi Cardiology Clinic
Institute
Department
Personal name
Funding Source
Organization
Snowden Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo bldg. 201, 13-4 Kodenma-cho, Nihonbashi, Chuo-ku, Tokyo 103-0001, Japan
Tel
03-5641-4133
niho-jimucho@well-sleep.jp
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
医療法人財団健康睡眠会 日本橋循環器科クリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/nu16081230
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/nu16081230
Number of participants that the trial has enrolled
120
Results
FSSG heartburn score was significantly improved at 6 weeks in LJ88 group compared to placebo one, although the FSSG total score, sub-scores, and other specific scores were not improved. No significant differences in changes between groups were observed in GSRS, stomach symptom questionnaire, serum gastrin, or POMS2. In SF-36v2, physical component summary (2 components universal) was significantly improved in LJ88 group compared to placebo one. No severe adverse events related to test foods were observed.
Results date posted
| 2024 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
<Participants>
All Participants (n = 120); Placebo Group (n = 60); LJ88 Group (n = 60)
<Sex>
All Participants (female, n = 67; male, n = 53); Placebo Group (female, n = 33; male, n = 27); LJ88 Group (female, n = 34; male, n = 26), p = 1.000
<Age (years)>
All Participants (46.7+/-10.2; 21-63); Placebo Group (46.9 +/-9.7; 23-63); LJ88 Group (46.5 +/-10.7; 21-63), p = 0.817
<Height (cm)>
All Participants (164.6+/-8.4); Placebo Group (164.7+/-8.7); LJ88 Group (164.6+/-8.1), p = 0.922
<Body weight (kg)>
All Participants (60.4+/-11.5); Placebo Group (60.6+/-11.5); LJ88 Group (60.3+/-11.5), p = 0.889
<BMI>
All Participants (22.2+/-3.2); Placebo Group (22.2+/-3.1); LJ88 Group (22.1+/-3.3), p = 0.887
<Systolic blood pressure (mmHg)>
All Participants (116.9+/-14.1); Placebo Group (119.2+/-15.2); LJ88 Group (114.7+/-12.7), p = 0.086
<Diastolic blood pressure (mmHg)>
All Participants (72.5+/-10.1); Placebo Group (73.0+/-10.9); LJ88 Group (72.1+/-9.4), p = 0.629
<Pulse rate (bpm)>
All Participants (69.0+/-8.8); Placebo Group (68.4+/-8.5); LJ88 Group (69.7+/-9.2), p = 0.434
<FSSG total score >
All Participants (22.2+/-5.8); Placebo Group (22.0+/-5.4); LJ88 Group (22.4+/-6.2), p = 0.805
Participant flow
<Allocation (Full Analysis Set)>
LJ88 group (n=60)
|-> Voluntarily declined (n = 1)
Placebo group (n=60)
<Follow-up (Full Intake Set)>
LJ88 group completed (n=59)
|-> Excluded (n = 7)
No timely acquisition of 6W data (n = 1)
FSSG total score < 8 at 0W
Placebo group completed (n=60)
|-> Excluded (n = 5)
Higher life rhythm disturbance (n = 1)
FSSG total score < 8 at 0W
< Analysis (Per-Protocol Set)>
LJ88 group (n = 52)
Placebo group (n = 55)
Adverse events
During the study, adverse events were observed in 24 of the 120 participants (13 and 11 in the placebo and LJ88 groups, respectively), and the total number of events was 38 (19 and 19 in the placebo and LJ88 groups, respectively). In the placebo group, the 19 adverse events comprised sore throat (1 case), cold (1 case), high glucose (1 case), swelling and pain in both eyelids (1 case), pollen allergy (3 cases), stomach ache (2 cases), periodontal disease (1 case), postmenopausal symptoms (2 cases), thumb cut (1 case), tired eyes (4 cases), fatigue (1 case), and nasal mucus (1 case). In the LJ88 group, the 19 adverse events comprised diarrhea (1 case), heavy stomach (1 case), nausea (1 case), malaise (1 case), unwellness via stress (1 case), fatigue (5 cases), abdominal bloating and too much gas (1 case), high triglyceride (1 case), dry eye (1 case), cold (1 case), pollen allergy (1 case), tired eye (2 cases), headache (1 case), and COVID-19 (1 case). None of these factors, however, was considered serious or related to the ingestion of either test food. No abnormal changes were detected in body weight, BMI, blood pressure, pulse rate (Table S2), blood biochemical test values (Table S3), blood cellular test results (Table S4), or urinalysis results (Table S5), although some statistically significant changes within normal ranges were observed for some items in both groups. In summary, these results suggest that both test foods (placebo and LJ88) were safe.
Outcome measures
Since the data for the outcome measures are voluminous, please refer to the published paper.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 18 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055669
