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Irritable Bowel SyndromeIBS-SMNCT03332537

Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome

A study testing Personalized IBS Pain SM in people with Irritable Bowel Syndrome, run by University of Connecticut at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot project will provide foundational information about the contextual factors of irritable bowel syndrome (IBS) related pain (pain catastrophizing, perceived stress, reactivity pain sensitivity, genetic and microbiome) on pain self-management (SM) process and outcomes. Read more about this study

Who is it for?
Ages 18 to 29 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Personalized IBS Pain SM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
1 Oct 2016to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women ages 18-29 years of age
  • Diagnosis of IBS from a healthcare provider with a current report of pain
  • Able to read and write in English
  • Daily access to a computer connected to the internet

Who cannot join

  • Other chronic painful conditions (i.e. fibromyalgia, chronic pelvic pain, or chronic interstitial cystitis)
  • Infectious disease (hepatitis, HIV, MRSA)
  • Celiac disease or inflammatory bowel disease
  • Diabetes Mellitus
  • Serious mental health conditions (ex. Bipolar disorder, schizophrenia, mania)
  • Women who are pregnant or post-partum in last 3 months
  • Regular use of opioids, iron supplements, prebiotics/probiotics or antibiotics, or substance abuse.
  • Injury to non-dominant hand or presence of open skin lesions

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UConn Health Center

    Farmington, Connecticut, 06030

  • University of Connecticut

    Storrs, Connecticut, 06269

Other trials in United States

About this study

This pilot project will provide foundational information about the contextual factors of irritable bowel syndrome (IBS) related pain (pain catastrophizing, perceived stress, reactivity pain sensitivity, genetic and microbiome) on pain self-management (SM) process and outcomes. In addition, the investigators will gain insight on the potential impact of the personalized IBS-pain SM approach on pain SM behaviors and health outcomes.

Read the detailed description

Intense, recurrent abdominal (visceral) pain is a predominant symptom of irritable bowel syndrome (IBS), a functional gut disorder that typically manifests in the early adult years. IBS is common with prevalence reaching over 20% in some regions of the world, and affects more women than men. While women report more severe IBS-related pain, both younger men and women report more severe pain compared to older adult cohorts. Direct costs of care and lost productivity in the U.S. exceed $21 billion annually, and individuals with IBS utilize more healthcare services than the general population, including outpatient visits, diagnostic testing and over-the-counter and prescription medications. Individuals with IBS report that pain is the most distressing symptom and has the greatest impact on quality of life, however, current approaches to improve self- management of IBS-related pain do not target individual, context-specific factors of pain. Therefore, individuals with IBS-related pain often endure a long and frustrating course of learning how to manage pain on their own accord. The proposed pilot project was developed based on this common situation and will provide feasibility data about the influence of providing a personalized pain SM intervention to individuals with IBS-related pain. IBS-related pain is associated with sensitization of the central nervous system, and approximately half of all patients with IBS have visceral hypersensitivity. These alterations in pain processing escalate pain perception, and can increase vulnerability to other co-morbid pain disorders which individuals with IBS frequently suffer. Pain sensitization is influenced by pain-sensitivity genes and, specific to IBS-related pain, the gut microbiome. Therefore, as contextual factors of pain associated with IBS, the investigators will measure peripheral and central sensitivity, single-nucleotide polymorphisms (SNPs) of candidate pain-sensitivity genes and the gut microbiome. The SM intervention was designed to provide factual information about IBS pain, triggers of pain and pain SM skills. The experimental group will receive one-on-one consultation tailored around the individual's assessment results of peripheral and central pain sensitivity as measured by quantitative sensory testing (QST) and targeted toward increasing pain self-efficacy and self-regulation skills and abilities. The proposed pilot project will provide foundational information about the contextual factors of IBS pain (pain catastrophizing, perceived stress, reactivity pain sensitivity, genetic and microbiome) on pain SM process and outcomes. In addition, the investigators will gain insight on the potential impact of the personalized IBS-pain SM approach on pain SM behaviors and health outcomes.

Being tested
Personalized IBS Pain SM
Keywords
Young Adults, IBS, Self Management, Pain, Gut microbiome, Genetics, Online education
Medical subject headings
Irritable Bowel Syndrome, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized IBS Pain SMBehavioural

Study groups in NCT03332537
Study groupRoleWhat they receive
ControlNo interventionParticipants will be provided an online interactive platform to access electronic modules (total of 10) on: IBS-related pain neurophysiology and the brain-gut axis and self-management strategies. There is no additional intervention.
Personalized IBS Pain SMExperimentalParticipants will be enrolled in the online platform. After completion of the modules, they will be scheduled for a consultation with a research nurse about their level of peripheral and central sensitivity, self-evaluation of IBS-pain SM, goal setting and self-monitoring of IBS-pain and physical activity. They will be asked to document their pain and all symptom SM behaviors daily for the next 10 weeks. At the 6-week follow-up visit, the researcher will review the online activities of the participant, go over the previously selected goals with the participants. The study nurse will acknowledge accomplishment of goals and assist in problem-identification and solving.
Receives: Behavioral: Personalized IBS Pain SM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain sensitivity

    Quantitative sensory testing - Change over time

    Measured: Baseline and 6 weeks and 12 weeks

  2. Change in gut microbiome

    Change over time

    Measured: Baseline and 6 weeks and 12 weeks

Secondary outcomes (1)

  1. Genetic variations (Pain-susceptibility SNPs genotyping)

    related to IBS-related pain and gut microbiome

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start1 Oct 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332537
Sponsor's protocol ID
H16-152
Other IDs
1P20NR016605-01
Acronym
IBS-SM
Status last verified
May 2019
First submitted
27 Oct 2017
Last updated
4 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website. When will data be available (start and end dates)? Immediately. No end date. With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov. By what mechanism will data be made available? Data are available at cdRNS.nih.gov

Publications

  • Chen J, Li A, Wu W, Xu W, Zhao T, Starkweather AR, Rodriguez L, Chen MH, Cong XS. Gut microbiota signatures differentiate trajectory-defined response phenotypes and predict self-management outcomes in irritable bowel syndrome. medRxiv [Preprint]. 2026 May 20:2026.05.18.26353470. doi: 10.64898/2026.05.18.26353470.

    PubMed 42238447

  • Chen J, Zhang Y, Barandouzi ZA, Lee J, Zhao T, Xu W, Chen MH, Feng B, Starkweather A, Cong X. The effect of self-management online modules plus nurse-led support on pain and quality of life among young adults with irritable bowel syndrome: A randomized controlled trial. Int J Nurs Stud. 2022 Aug;132:104278. doi: 10.1016/j.ijnurstu.2022.104278. Epub 2022 Apr 30.

    PubMed 35640500

Questions about this trial

What is this clinical trial studying?

A study testing Personalized IBS Pain SM in people with Irritable Bowel Syndrome, run by University of Connecticut at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain sensitivity (time frame: Baseline and 6 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332537, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.

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