Synbiotic preparation in young men suffering from functional constipation, a randomized clinical trial.

Synbiotic preparation containing Lactobacillus Spp., Bifidobacter Spp. and Fructo-oligo-saccharide in alleviating constipation symptoms in young men suffering from functional constiption

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138802151873N1

Enrollment

Registered

2009-06-10

Start date

2008-05-10

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

functional constipation. other functional intestinal disorders-constipation

Interventions

Intervention 1: Intervention group: Synbiotic capsule, containing 108 CFU of Lactobacillus spp., Bifidobacter spp., S.Thermophilus and Prebiotic: Fructooligosaccharide (commercial name: Protexin, Lond

Treatment - Drugs

Placebo

Intervention group: Synbiotic capsule, containing 108 CFU of Lactobacillus spp., Bifidobacter spp., S.Thermophilus and Prebiotic: Fructooligosaccharide (commercial name: Protexin, London, UK), twice a

Control group: placebo capsule with the same shape and color, twice a day (after breakfast and after dinner) for 4 weeks

Eligibility

Sex/Gender

Male

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Male sex, age 18-40 years, Fulfill Rome III criteria, giving informed consent Exclusion criteria: Presence of alarming symptoms like fever, recent weight loss, LAP, anemia, presence of any systemic disorder like Diabetes Mellitus or nervous system disorder like M.S., history of gastrointestinal surgery

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Stool form and consistency. Timepoint: Baseline, weeks 2 and 4. Method of measurement: Bristol stool form scale.;Bowel movement frequency per week. Timepoint: Baseline, weeks 2 and 4. Method of measurement: Designed questionnaire.;Severity of constipation symptoms. Timepoint: Baseline, weeks 2 and 4. Method of measurement: PAS-sym questionnaire.	—

Secondary

Measure	Time frame
Effectiveness of treatment. Timepoint: Baseline and week 4. Method of measurement: Designed questionnaire.;Need to use manual maneuvres. Timepoint: Baseline and week 4. Method of measurement: Designed questionnaire.;Use of laxatives. Timepoint: Baseline and week 4. Method of measurement: Designed questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRouzbeh Fateh

Tehran University of Medical Sciences

rouzbehfateh@student.tums.ac.ir / rouzfa@yahoo.com+98 21 2242 7617

Outcome results

None listed

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