Effects of probiotics in patients with functional diarrhea with inflammation in the stool

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0006776
• Lead Sponsor: Ajou University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-15
• Last Update Posted: 2 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

i).Rome III standards are as follows.
Abdominal discomfort or pain for 3 or more days in the past 3 months and the following 3 symptoms - (1) symptoms relieved after defecation, (2) symptoms started with a change in the frequency of bowel movements, (3) accompanied by a change in stool form with onset of symptoms - when two or more of these occur.
ii). Rome IV criteria are as follows.
Symptoms started 6 months ago and within the last 3 months (1) Dissolved stools without abdominal pain or severe bloating (2) Dissolved stools more than 25%
- Those who are 19 years of age or older
- Those who have no organic lesions in the colon during colonoscopy within the last 2 years

iii) Fecal calprotectin levels >11.5 mg/kg

Exclusion Criteria

- Organic bowel disease (Crohn's disease, celiac disease, ulcerative colitis, malignant tumor of the colon)
- In case of previous bowel surgery except appencdectomy)
- In case of liver cirrhosis, liver cancer, chronic renal failure, congestive heart failure, hypo/hyperthyroidism, etc.
- If there are warning symptoms such as rectal bleeding or weight loss of 10% or more within the last 6 months
- If the subjects have recently traveled to an area with an epidemic parasitic disease
- Pregnant women, lactating women, etc.
- Genetic diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of changes in the ratio of loose stools and stool calprotectin levels after 2 months from baseline in probiotics and placebo groups

Secondary Outcome Measures

Name	Time	Method
Comparison of fecal bacterial flora and cell membrane resistance after 2 months compared to baseline in probiotic group and placebo group