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

NCT04193501 | Unknown Phase 3 DMC

• 1 other identifier: 2018-207-EMP-107
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Melatonin; gut microbiota; dysbiosis

Outcome Measures

Primary Outcomes (2)

• Change in levels of 6-Hydroxymelatonin sulphate

  To study changes from baseline, in levels of 6-Hydroxymelatonin sulphate (a metabolite of melatonin) both in patients with IBS and healthy controls

  1 month

• Sleep quality index score

  Self-reported usual sleep habits for the majority of days and nights during the past month only. The 19 self-rated and 5 non-self rated questions combined to form seven component scores, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties.

  1 month

Secondary Outcomes (1)

• Change in IBS symptom severity scores

  1 month and 3 months

Study Arms (2)

Experimental arms

EXPERIMENTAL

Melatonin dose: 3mg/OD

Drug: Melatonin 3 mg

Control arms

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Melatonin 3 mg DRUG

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.

Also known as: 5-Methoxy-N-Acetyltryptamine

Experimental arms

Placebo OTHER

Similar looking placebo

Control arms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis by ROME III/IV criteria.
• Willing to participate and informed consent is obtained.

You may not qualify if:

• Presence of alarm symptoms such as severe organic GI diseases, unexplained iron deficiency anemia, unintentional weight loss, palpable abdominal mass.
• No active substance intake.

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (2)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

Lucknow, Uttar Pradesh, 226014, India

NOT YET RECRUITING

Related Publications (1)

• Ghoshal UC, Shukla A. Malnutrition in inflammatory bowel disease patients in northern India: frequency and factors influencing its development. Trop Gastroenterol. 2008 Apr-Jun;29(2):95-7.

  PMID: 18972769 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dysbiosis

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Uday C Ghoshal

  Medical council of India, Association of Indian Universities

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uday C Ghoshal

CONTACT

05222494405; udayghoshal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and Investigator Blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Placebo Controlled Trial

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: December 10, 2019
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 16, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)