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Frequency of Sleep Abnormalities in Patients With Irritable Bowel Syndrome and Effect of Pharmacological Intervention

NCT04193501 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2020-03-16

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS), a common gastrointestinal (GI) disorder in India and in the rest of the World, is enigmatic in its pathogenesis. IBS is associated with recurrent abdominal pain or discomfort, bloating, incomplete evacuation, altered bowel habits, and abnormal stool forms. The etiology of IBS remains unclear and different factors were thought to be involved like genetics and environmental factors, visceral hypersensitivity, altered gut microbiota or disorder of the microbiota-gut-brain axis and various psychological factors like anxiety, depression, and insomnia or sleep disturbance. Due to increasing work pressure in today's society, and the consequent shift duty and psychological stress, the frequency of sleep disorders is increasing; disturbed sleep may be associated with a vicious cycle in which altered sleep may result in gastrointestinal (GI) disturbances, which in turn, may jeopardize sleep further. The disorder of the gut microbiota, the largest organ of the human body, is being suggested to be responsible for several GI and extra-GI diseases. Qualitative change in gut microbiota is currently studied by next-generation sequencing. Gut and sleep patterns work in an axis - a two-way street of communication, some studies reported altered gut microbiota or dysbiosis modulates peripheral and central nervous system function, leading to alterations in brain signaling and behavior that possibly leads to sleep disturbances.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Melatonin 3 mg

Melatonin dose: 3mg/OD Melatonin is a hormone made by the pineal gland; its biosynthesis is initiated by the uptake of the essential amino acid tryptophan and is an important inducer of sleep. Abnormality in melatonin has been shown in several studies on patients of IBS and functional constipation.

OTHER

Placebo

Similar looking placebo

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Uday C Ghoshal · Medical council of India, Association of Indian Universities

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-02-28
Completion
2022-02-28

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04193501 on ClinicalTrials.gov