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

The Efficacy of Lactobacillus plantarum CJLP243 in Patients With Non-constipated Irritable Bowel Syndrome or Functional Diarrhea with High Fecal Calprotectin Levels; A Randomized, Double-blind, Placebo-controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006776

Enrollment

Registered

2021-11-23

Start date

2020-10-01

Completion date

Unknown

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(probiotics) : The selected subjects are randomly assigned to a placebo group and a probiotic group, respectively, and the subjects take the test food orally for 2 months. The test food is Lacto

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactKYUNAM KIM

Ajou University Hospital

ktwonm@hanmail.net+82-31-219-5309

Outcome results