The effect of lactol on treatment of irritable bowel syndrome

The effectiveness of lactol compared with placebo on symptoms of patients with irritable bowel syndrome referred to GI clinic

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201206179995N4

Enrollment

Registered

2012-09-08

Start date

2012-08-15

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

Irritable bowel syndrome. Irritable bowel syndrome with diarrhea

Interventions

Intervention 1: Intervention group 1: Lactol tablet twice daily for 8 weeks. The drug is manufactured under license of Nature's Only Company of USA in India. Each tablet contains 100 mg Fructo-Oligos

Treatment - Drugs

Placebo

Intervention group 1: Lactol tablet twice daily for 8 weeks. The drug is manufactured under license of Nature's Only Company of USA in India. Each tablet contains 100 mg Fructo-Oligosaccharides and 1

Intervention group 2: Placebo twice daily for 8 weeks. The placebo is made same the lactol under the supervision of pharmaceutist in the Kermanshah University of Medical Sciences School of Pharmacy.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Abdominal pain or GI discomfort for at least three months in a year and two of following symptoms: pain relief after defecation, change in frequency of defecation with the onset of symptoms, change in fecal consistency with the onset of symptoms. Exclusion criteria: severe IBS and celiac disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Abdominal pain. Timepoint: Before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= sometimes, 2= persistent, 3= severe and disabling.;Fecal consistency. Timepoint: before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0=NA, 1=solid, 2=watery, 3= mucosal.;Change frequency of defecation. Timepoint: before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0= without change, 1= Decrease frequency of defecation, 2= Increase frequency of defecation.	—

Measure

Time frame

Abdominal pain. Timepoint: Before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= sometimes, 2= persistent, 3= severe and disabling.;Fecal consistency. Timepoint: before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0=NA, 1=solid, 2=watery, 3= mucosal.;Change frequency of defecation. Timepoint: before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0= without change, 1= Decrease frequency of defecation, 2= Increase frequency of defecation.

—

Secondary

Measure	Time frame
Bloating. Timepoint: Before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= some times, 2= persistent, 3= severe.;Incomplete evacuation. Timepoint: Before,4 and 8 weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= some times, 2= often, 3= always.;Urgency. Timepoint: Before,4 and 8 weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= some times, 2= frequent urgency, 3= fecal incontinency.	—

Measure

Time frame

Bloating. Timepoint: Before, four and eight weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= some times, 2= persistent, 3= severe.;Incomplete evacuation. Timepoint: Before,4 and 8 weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= some times, 2= often, 3= always.;Urgency. Timepoint: Before,4 and 8 weeks after trial. Method of measurement: Questionnaire and examination; 0= NA, 1= some times, 2= frequent urgency, 3= fecal incontinency.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Ali Asghar Keshavarz

Imam Reza Hospital

akeshavarz@kums.ac.ir+98 83 1427 6310

Outcome results

None listed

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