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Assessment the effect of a drug in the treatment of abdominal pain in children

Assesment the effect of synbiotic in the treatment of functional abdominal pain in children

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190304042914N1
Enrollment
64
Registered
2019-05-25
Start date
2019-02-19
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Functional abdominal pain. Other and unspecified abdominal pain

Interventions

Intervention 1: Intervention group: Daily, 2 Sinobiotic sachets are consumed every 12 hours soluble in water or juice for one month. Intervention 2: Control group:Daily, 2 Placebo are consumed every 1

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: FAP diagnosis based on Rome III criteria

Exclusion criteria

Exclusion criteria: Immunodeficiency Consumption of probiotics or prebiotics within 7 days before participating in the study Chronic underlying disease Malignancy The presence of red flags includes a pain that awakens the baby Continuous pain of RUQ or RLQ Vomiting (biliary, frequent, periodic, or disturbing for the physician) Fever without cause Urogenital Symptoms Dysphagia Severe chronic diarrhea or Nocturnal diarrhea Gastrointestinal bleeding Unwanted weight loss Downtrend in the growth curve Delayed puberty Family history of IBD Celiac and PUD Localized tenderness in RUQ or RLQ Localized mass Splenomegaly Jaundice CVA tenderness Arthritis Vertebral tenderness Disease in the perianal area Abnormal or unreasonable findings in the examination Hematochezia Anemia Hepatomegaly Antibiotic use in the last month

Design outcomes

Primary

MeasureTime frame
Frequency of pain. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: check list.

Secondary

MeasureTime frame
Number of absentee days from school. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Check list.;Pain intensity. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Face scaling.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh gholizadeh

Babol University of Medical Sciences

gholizadeh.a.84@gmail.com+98 11 3235 4951

Outcome results

None listed

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