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comparison of peppermint and synbiotic in functional abdominal pain

Comparison between standard peppermint oil and synbiotic (bacillus coagulans + FOS ) in severity, duration, and frequency of abdominal pain in childhood pain related GI functional disorders in 4-18 yrs old patients in Imam Khomeini Hospital of Tehran. randomized and placebo- controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012110711392N1
Enrollment
120
Registered
2013-01-25
Start date
2013-02-19
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

abdominal pain. functional diarrhoea- functional disorders of stomach-Dyspepsia - Functional intestinal disorder, unspecified -Flatulence and related conditions -Other and unspecified abdominal pain -Change in bowel habit -Irritable bowel syndrome with diarrhoea - I

Interventions

Intervention 1: olpermin cap 187 mg antemeal TDS for 1 month. Intervention 2: lactol tab (150 ms bacillus coagulans + FOS ) aftermeal TDS for 1 month. Intervention 3: folic acid tab 1 mg daily for 1 m
Treatment - Drugs
olpermin cap 187 mg antemeal TDS for 1 month.
lactol tab (150 ms bacillus coagulans + FOS ) aftermeal TDS for 1 month.
folic acid tab 1 mg daily for 1 month.

Sponsors

Medica School , Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 18 Years

Inclusion criteria

Inclusion criteria: any patient with abdominal pain and age range of 4-18 yrs who seeks medical advice and fulfills Rome III criteria for abdominal pain related functional GI disorders will be entered in this study if be consented. patients will be excluded from study if any alarm sign or red flag such as RUQ or RLQ pain- wt loss or growth impairment- dysphagia-vomiting- anemia- diarrhea (specially nocturnal ) - fever - arthritis - familial history of IBD - or findings suggestive of organic pain be found . any patient or parent whom won,t be consented or won,t follow therapy will be excluded.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Abdominal pain severity. Timepoint: one month after treatment and 3 mo after end of treatment. Method of measurement: asking question from parents and patients based on VAS and NRS scoring.;Abdominal pain frequency. Timepoint: 1 month after treatment and 3 months after end of treatment. Method of measurement: asking question from patient and parents.;Abdominal pain duration. Timepoint: 1 month after treatment and 3 months after end of treatment. Method of measurement: asking question from patient and parents.

Secondary

MeasureTime frame
Dyspepsia signs such as fullnes, discomfort, belching and flatulence. Timepoint: one mo after treatment and 3 mo after end of treatment. Method of measurement: asking question from parents and patients.;Defecation abnormality like constipation and diarrhea. Timepoint: 1 months after treatment and 3 months after end of treatment. Method of measurement: asking question from patient and parents.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsgarshirazi M. M.D

Medical school , Tehran University of Medical Sciences

dr_m_asgarshirazi@yahoo.com+98 21 6658 1596

Outcome results

None listed

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