Efficacy of double coated probiotics for irritable bowel syndrome

Efficacy of double coated probiotics for irritable bowel syndrome : a randomized double-blind clinical study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001226

Enrollment

Registered

2014-09-15

Start date

2014-06-19

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : randomized participants were prescribed to either double coated lactic acid bacteria 700mg or uncoated lactic acid bacteria 700mg to administer once a day at each visit for total 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?. All men and women aged between 19 and 65 years ?. Patients who can read and write characters ?. Patients who are reasonable irritable bowel syndrome symptoms(IBS) with diarrhea in Rome ? criteria ?. Patients who will agree to notice the staff when taking of the new drugs whithin five weeks after starting study ?. Patients who have no organic diseases whithin 2 years ?. patients who have been explained about the trial and agreed to the consent

Exclusion criteria

Exclusion criteria: ?. Patients who underwent abdominal surgery(except, appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, abdominal wall hernia repair) ?. Patients who have digestive organic diseases (ex. cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer) ?. Patients who have Alarm symptoms(Severe weight loss, Melena, Dysphagia...) ?. Patients who had received over-the-count medication before screening(within three days) (? antispasmodic : Cimetropium, Mebevarine, Pinaverium, Trimebutine... ? Prokinetics : motilium, Levopride, itopride, mosapride... ? Antidepressant : Tricyclic antidepressants, SSRI (selective serotonine reuptake inhibitor), ? Antidiarrhea : loperamide) ?. Patients with chronic diseases(acute inflammation, malignancy, renal disease, liver disease) ?. Pateints who had received antibiotics, herbal medicine or probiotics within 4 weeks before screening ?. Pregnant women, breast-feeding women.(except patients who had received negative pregnancy urine test or adequate contraception within 48hours before screening) ?. Patients who don't agree on randomized assignment

Design outcomes

Primary

Measure	Time frame
adequate relief(AR);Percentage of people with improved symptoms of 50% or more	—

Secondary

Measure	Time frame
Bowel function score, Symptom score, IBS quality of life;Bristol stool form scale;quality of life;blood test;Intestinal microbial analysis	—

Countries

Korea, Republic of

Contacts

Public ContactHojun Kim

Dongguk University Ilsan Hospital

Outcome results