Evidence map›Paper›PMID 38778264›Full record

ArticleBMC gastroenterology2024

Morning light treatment for inflammatory bowel disease: a clinical trial.

Shirley Cohen-Mekelburg, Cathy A Goldstein, Muneer Rizvydeen, Zainab Fayyaz, Priya J Patel, Jeffrey A Berinstein, Shrinivas Bishu, Kelly C Cushing-Damm, Hyungjin Myra Kim, Helen J Burgess

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06094608 (IBD-Sleep), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06094608 nacompletednot on this map

IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms

TypeinterventionalSponsorUniversity of MichiganRan2024 to 2026Enrolled64ConditionsInflammatory Bowel Diseases, Ulcerative Colitis, Crohn DiseaseArmsMorning light treatment, Treatment-as-usual
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Shirley Cohen-MekelburgDivision of Gastroenterology and Hepatology, University of Michigan Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA. shcohen@med.umich.edu.
Cathy A GoldsteinDepartment of Neurology, University of Michigan, Ann Arbor, MI, USA.
Muneer RizvydeenSleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Zainab FayyazSleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Priya J PatelSleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Jeffrey A BerinsteinDivision of Gastroenterology and Hepatology, University of Michigan Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.
Shrinivas BishuDivision of Gastroenterology and Hepatology, University of Michigan Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.
Kelly C Cushing-DammDivision of Gastroenterology and Hepatology, University of Michigan Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.
Hyungjin Myra KimConsulting for Statistics, Computing and Analytics Research, University of Michigan, Ann Arbor, MI, USA.
Helen J BurgessSleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.

Funding

Michigan Institute for Clinical and Health Research (MICHR)UM1TR004404 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Julie C Lumeng · 2023 to 2026
$39.8M
Morning Light Treatment for Inflammatory Bowel Disease: A Pilot Clinical TrialR01DK136520 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BURGESS, HELEN JULIA, GOLDSTEIN, CATHY ANNE · 2023 to 2025
$924k
CD4+ Tissue resident memory T-cells in Crohn's DiseaseK08DK123403 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BISHU, SHRINIVAS · 2020 to 2024
$848k
Development of Patient-Tailored Adaptive Treatment Strategies for Acute Severe Ulcerative ColitisK23DK134764 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Jeffrey Berinstein · 2023 to 2026
$777k
Precision Medicine in Inflammatory Bowel Disease: Refining the Clinical and Genomic Predictors of Response to Anti-IL-12/23 TherapyK08DK133640 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Kelly Colleen Cushing-Damm · 2023 to 2026
$669k
Foundation for the National Institutes of Health K08DK123403Foundation for the National Institutes of Health K08DK133640Foundation for the National Institutes of Health K23DK134764NCATS NIH HHS UM1 TR004404NIDDK NIH HHS K08 DK123403NIDDK NIH HHS K08 DK133640NIDDK NIH HHS K23 DK134764NIDDK NIH HHS R01 DK136520
6 · The paper itself

Abstract

backgroundInflammatory bowel disease (IBD) affects over 3 million Americans and has a relapsing and remitting course with up to 30% of patients experiencing exacerbations each year despite the availability of immune targeted therapies. An urgent need exists to develop adjunctive treatment approaches to better manage IBD symptoms and disease activity. Circadian disruption is associated with increased disease activity and may be an important modifiable treatment target for IBD. Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, but no studies have explored these potential therapeutic benefits in IBD. Therefore, in this study, we aim to test the effectiveness of morning light treatment for patients with IBD.

methodsWe will recruit sixty-eight individuals with biopsy-proven IBD and clinical symptoms and randomize them to 4-weeks of morning light treatment or 4-weeks of treatment as usual (TAU), with equivalent study contact. Patient-reported outcomes (IBD-related quality of life, mood, sleep), clinician-rated disease severity, and a biomarker of gastrointestinal inflammation (fecal calprotectin) will be assessed before and after treatment. Our primary objective will be to test the effect of morning light treatment versus TAU on IBD-related quality of life and our secondary objectives will be to test the effects on clinician-rated disease activity, depression, and sleep quality. We will also explore the effect of morning light treatment versus TAU on a biomarker of gastrointestinal inflammation (fecal calprotectin), and the potential moderating effects of steroid use, restless leg syndrome, and biological sex. DISCUSSION: Morning light treatment may be an acceptable, feasible, and effective adjunctive treatment for individuals with active IBD suffering from impaired health-related quality of life.

trial registrationThe study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024.

Indexed as

Circadian RhythmInflammatory Bowel DiseasesPhototherapyQuality of LifeAdultBiomarkersClinical Trials as TopicFecesFemaleHumansLeukocyte L1 Antigen ComplexMalePatient Reported Outcome MeasuresSeverity of Illness IndexSleep QualityTreatment OutcomeBiomarkersLeukocyte L1 Antigen ComplexCrohn’s diseaseLight treatmentSleepUlcerative colitis

Identifiers

PMID38778264
PMCPMC11110384

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.