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The verification of mitigating effect of probiotics on small bowel injury induced by aspirin (Probiotics trial)

Probiotics trial (Probiotics trial)

60

Eighteen patients in the control group, 17 patients in the PPI/P-CAB group, and 16 patients in the aspirin group were eligible for the primary endpoint. Control group (mean age 72.2 + 6.2, male 7), PPI/P-CAB group (mean age 73.6 + 7.7, male 9), Aspirin/PPI or P-CAB (mean age 74.8 + 8.9, male 12).

Sixty patients were recruited into the clinical trial. However, one patient in the control group and two in the PPI group withdrew their consent. In addition, one patient in the control group provided insufficient stool sample to extract DNA, one patient in the PPI group used antibiotics, and four patients in the Aspirin group dropped out because they only took aspirin but not taking PPI or P-CAB.

No new diseases or serious adverse events occurred during the clinical trial.

The analysis of fecal microbiota before and after intaking Lactobacillus gasseri (LG) showed no difference in alpha-diversity among the three groups. In contrast, beta-diversity showed significant differences between the control and PPI groups and between the control and aspirin groups before probiotic intake. However, these differences disappeared after intaking LG. Analysis of the ileal microbiota showed no differences in alpha-diversity and beta-diversity among the three groups. Fecal calprotectin did not change significantly before and after taking LG in any of the groups

These results showed that LG improved the intestinal dysbiosis caused by aspirin and PPI administration and provided the sufficient potential for the future clinical application of probiotics in preventing and treating aspirin-induced small bowel injury.

Mar. 31, 2024

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs031200395

Suzuki Takayoshi

Tokai University Hachioji Hospital

1838 Ishikawa-machi, Hachioji, Tokyo, Japan

takayosh@is.icc.u-tokai.ac.jp

Nagata Junko

Tokai University Hachioji Hospital

1838 Ishikawa-machi, Hachioji, Tokyo, Japan

+81-42-639-1111

nagata.junko@hachioji-hosp.tokai.ac.jp

Complete

Mar. 04, 2021

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Older than 20 y.o.
2) Patients who plan to have a colonoscopy
3) Patients who gave written informed consent before entry in this study

1) Patients who received antibiotics within 6 months before registration
2) Patients who regularly use other lactic acid bacteria preparations
3) Patients allergic to dairy products
4) A person who is determined to be inappropriate by the research director or co-workers

Both

Aspirin-induced small bowel injuries

Probiotics (Lactobacillus gasseri/OLL2716) are administered for 6 weeks to the control group, the proton pump inhibitor oral administration group, and the aspirin and proton pump inhibitor oral administration group.

Aspirin-induced small bowel injuries

Probiotic

Intestinal bacterial profile in the stool

1) Tight junction damage
2) COX expression
3) Amounts of mucosal prostaglandins
4) Existence ratio of immune cells
5) Intestinal bacterial profile (wash, biopsy tissue)
6) Amounts of calprotectin in the stool

+81-463-93-1121

Feb. 03, 2021

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