Examination of the probiotics for chronic constipation symptoms (PCC Trial)

Completed

Conditions: Chronic constipation

Registration Number: jRCTs031210344

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.Males and females between 65 and 90 years of age at the time of consent. 2.Patients who have been diagnosed with chronic constipation by ROME IV. 3.Patients who have given their written consent to participate in this study.

Exclusion Criteria

1.Patients corresponding to 6 (muddy stool) and 7 (watery stool) on the Bristol Stool Form Scale. 2.Patients who have or are suspected of having abnormal recto-anal function. 3.Patients who have been diagnosed with organic abnormalities that cause constipation by colonoscopy within 5 years. 4.Patients with a history of surgical resection of the stomach, gall bladder, small intestine, or large intestine (except for appendicitis and benign polypectomy). 5.Patients with a history of or currently suffering from celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), or ischemic colitis. 6.Patients who currently have infectious enteritis. 7.Patients with obvious mechanical obstruction (intestinal obstruction due to hernia, etc.), giant colon, or giant rectum. 8.Patients who have had or are currently suffering from malignant tumors of the digestive system (except for gastrointestinal cancers that have been cured by endoscopic treatment). 9.Patients who are currently suffering from serious cardiovascular, respiratory, renal, hepatic, digestive (except for chronic constipation), hematological, neurological, or psychiatric diseases (including insomnia with constant use of sleeping pills, but not including patients who take sleeping pills only for insomnia). 10.Patients who have had or are currently suffering from Parkinson's disease. 11.Patients who are currently suffering from hyperthyroidism or hypothyroidism. 12.Patients who have participated or are currently participating in clinical trials, post-marketing clinical trials, or clinical research for other ethical drugs or medical devices within three month prior to obtaining consent. 13.Patients who are abusing alcohol and drugs. 14.Patients with a history of allergy caused by the study drug (study drug: lactobacillus, saccharobacillus, butyric acid bacteria, additives). 15.Patients who regularly use probiotics other than the protocol treatment (However, even if they have been discontinued more than 2 weeks prior to enrollment.) 16.Patients who regularly use medicines that affect bowel movements (antibiotics, diarrheals) or health foods/supplements (lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, etc. However, foods such as yogurt are acceptable.). 17.Other patients who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.

Study & Design

Study Type: Interventional

Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Amount of change in defecation score on the Bristol Stool Form Scale	between pre-treatment and treatment week 8 (day 56)	The stool properties score (1-7) on the Bristol Scale is used as the score, and the score is set to "0" on days when there is no defecation. Defined as the total of the values obtained by subtracting 4, which is considered to be a normal stool on the Bristol Scale, for 7 consecutive days. If there is a missing measurement in seven consecutive days, the average value of the data excluding the missing days is adopted.

Secondary Outcome Measures

Name	Time	Method
Amount and rate of change in the number of bowel movements	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	7-day average between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56). If there is a missing measurement in seven consecutive days, the average value of the data excluding the missing days is adopted.
Amount of change in the defecation score of the Bristol Stool Form Scale	pre-treatment to treatment week 4 (day 28)	between pre-treatment and treatment week 4 (day 28).
Amount and rate of change in JPAC-QOL total score and each subscale score	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56).
Amount and rate of change in ModifiedCSS (mCSS) total score and each endpoint	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56).
Amount and rate of change in each questionnaire score	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56). Izumo scale, and DVS (food diversity questionnaire)
Amount and rate of change in the severity of strain score	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	7-day average between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56). The difference in the severity of strain is in 5 levels (1: no strain, 2: slight strain, 3: some strain, 4: strong strain, 5: very strong strain). If there is a missing measurement in seven consecutive days, the average value of the data excluding the missing days is adopted.
Amount and rate of change in nutritional status assessment	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56).
Variation and rate of change in intestinal microflora	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56). Comparison of intestinal microbiota (Butyrate-producing bacteria occupancy and others), diversity analysis, principal coordinate analysis, LEfSe analysis
Amount and rate of change in TG/HDL-C ratio	pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56)	between pre-treatment and treatment week 4 (day 28), and between pre-treatment and treatment week 8 (day 56).