Effects of Probio-Tec QUATRO-cap-4 in Patients with bloating predominant irritable bowel syndrome

Effects of Probio-Tec QUATRO-cap-4 in Patients with bloating predominant irritable bowel syndrome in a Randomized, Placebo-controlled double blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012071010230N1

Enrollment

120

Registered

2012-09-29

Start date

2010-02-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Bloating predominant Irritable bowel syndrom. Irritable bowel syndrome without diarrhoea

Interventions

Treatment - Drugs

Placebo

Intervention 1: Intervention: Probio-Tec QUATRO-cap-4 is encapsulated and will be given twice a day for 1 month. Intervention 2: control:Placebo is encapsulated and will be given twice a day for one

Intervention: Probio-Tec QUATRO-cap-4 is encapsulated and will be given twice a day for 1 month

control:Placebo is encapsulated and will be given twice a day for one month.

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: having bloating- predominant irritable bowel syndrome(IBS); agreed to participate in research and signing the consent form; Patients must be between the ages of 20-70 years old. Exclusion criteria: age of onset of discomfort greater than 50 years; a steady progressive course; complaints which frequently leads to awakening the patient from sleep; presence of fever or weight loss; dehydration (due to clinical symptoms); opioid drugs (based on patient history); pregnancy or lactation; using Laxatives and effective drugs on intestinal motility, anti-diarrhea drugs, Symbiotic, other probiotics , antibiotics and any other effective drugs in IBS medication must be avoided during two weeks before the start of the run in period and whole of the study; Dementia or severe mental disease; inflammatory bowel disease (IBD) ; gastrointestinal cancers; severe systematic disease, diabetes, hypothyroidism; immunodeficiency; performed abdominal surgery except appendectomy, cesarean section, tubal ligation, laparoscopic procedure cholecystectomy, hysterectomy, hernia repair abdominal wall; abnormal breath test for lactose intolerance; improvement in symptoms after taking metronidazole ;documented evidence of probiotic intolerance; Failure to cooperate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Reduction in severity of bleeding in patients. Timepoint: before,during and one month after intervention. Method of measurement: visual assessment scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Homayoon Vahedi

Digestive diseases research center, Tehran university of medical science

vahedi@ams.ac.ir+98 21 8241 5104

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 20, 2026