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probiotics in Irritable bowel syndrome

Effect of multispecies probiotic supplementation on Irritable bowel syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181231042191N1
Enrollment
50
Registered
2019-04-18
Start date
2019-04-20
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: Patients will receive two 500 mg Familact® probiotic capsules, produced by Tehran Zisttakhmir Company, daily for 30 consecutive days. To maximize absorption, the ti

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients will be selected based on the Rome II criteria according to the gastroenterologist diagnosis ; (Rome II criteria: abdominal pain or any digestive discomfort for at least 3 months during the last year that can be consecutive or non-consecutive, along with two of the three following items: relieving pain by defecation, starting symptoms associated with change in the frequency of bowel movements, starting symptoms associated with change in the shape of feces) Age of at least 18 years old The informed consent of the patient, which is submitted in writing form after all necessary explanations are given to him/her.

Exclusion criteria

Exclusion criteria: History of major gastrointestinal surgery chronic use of antibiotics, corticosteroids and immunosuppressive drugs Regular use of drugs that alter gastrointestinal movements such as metoclopramide, cisapride, domperidone, narcotics especially opioid derivatives, laxatives, anti-diarrheal agents, as well as other effective drugs for the treatment of IBS, as described in more detail in the text. Presence of severe psychological and behavioral disorders in the patient Food allergy History of any organic bowel disease or chronic digestive illness

Design outcomes

Primary

MeasureTime frame
Severity of abdominal pain: discrete quantitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: The questionnaire (numbers from 0 to 10 to assess the severity of the abdominal pain; zero indicates no pain and 10 indicates pain is very severe).;Amount of abdominal discomfort: discrete quantitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: The questionnaire (numbers from 0 to 10 to assess the amount of the abdominal discomfort; zero indicates no discomfort and 10 indicates very severe discomfort).;Amount of bloating and/or abdominal swelling: discrete quantitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: The questionnaire (numbers from 0 to 10 to assess the amount of the bloating and/or abdominal swelling; zero indicates no bloating and/or abdominal swelling and 10 indicates bloating and/or abdominal swelling is very severe).;Heartburn: Nominal qualitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: Questionnaire (has / not).;Nausea: Nominal qualitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: Questionnaire (has / not).;The bowel habits (in terms of frequency of defecation and stool consistency) than before the onset of treatment: Nominal qualitative dependent variable. Timepoint: At the end of the study (end of the intervention). Method of measurement: Questionnaire (worse / no change / better).;Improvement of overall IBS symptoms than before starting the treatment: N

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMersad Amery

Islamic Azad University

mersadamery@yahoo.com+98 25 3778 7610

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026