Inflammatory Bowel DiseasesNCT04757935
Yoga for Youth With IBD: a Pilot Feasibility Study
A study testing Yoga in people with Inflammatory Bowel Diseases and Yoga, run by Stanford University at 1 site in United States.
Trial summary
An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Yoga, Adolescents
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 May 2017
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10-21
- Diagnosis of Crohn's Disease or Ulcerative Colitis
- Patient of a Stanford Children's Health or Stanford-affiliated Pediatric Gastroenterologist
- Ability to attend in-person meetings/training
Who cannot join
- Initiation of biologic therapy in prior 3 months
- Hospital admission in prior 2 months
- Major surgery in prior 1 month
- PUCAI/PCDAI >65
- Current pregnancy
- Severe developmental or intellectual disability
- Non-english speaking
- Not participating in another concurrent clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study
An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population.
Read the detailed description
Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering related to their disease process. While many biologic and non-biologic therapies are available to target the inflammatory component of IBD, youth with IBD could benefit from a more holistic therapy that addresses psychological wellness, which has been shown, in turn, to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares. It is also known that mind-body intervention reduces stress. The mind-gut connection is widely discussed in medical circles, however, current therapies have not capitalized on it. The investigators would like to know if an easily accessible mind-body intervention (yoga) can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with IBD.
The study will be an 8-week feasibility pilot. Participants will be asked to participate in online yoga videos and in-studio yoga sessions. Participants will be asked to complete multiple surveys throughout the intervention and continue receiving standard care from their primary gastroenterology team.
- Being tested
- Yoga
- Keywords
- inflammatory bowel disease, adolescent, yoga, mind-body
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of acceptability
Focus Group
Measured: 1 hour focus group at conclusion of intervention.
Secondary outcomes (3)
Fecal Calprotectin
Stool biomarker that indicates intestinal inflammation
Measured: 6 weeks (Prior to intervention; After conclusion of intervention)
Pediatric Ulcerative Colitis Activity Index
5 question assessment tool for disease tracking for patient's with ulcerative colitis
Measured: 6 weeks (Prior to intervention; After conclusion of intervention)
PROMIS-37
NIH Pediatric Assessment Tool
Measured: 6 weeks (Prior to intervention; After conclusion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jan 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Ming Yeh, MD, Principal investigator, Clinician Educator at Stanford UniversityJenna Marie Arruda, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757935
- Sponsor's protocol ID
- IRB Protocol 37755
- Status last verified
- Feb 2021
- First submitted
- 6 Sep 2018
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04757935
- Acronym / sponsor ID
- IRB Protocol 37755
- Keywords
- inflammatory bowel disease, adolescent, yoga, mind-body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population.
Detailed description
Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering related to their disease process. While many biologic and non-biologic therapies are available to target the inflammatory component of IBD, youth with IBD could benefit from a more holistic therapy that addresses psychological wellness, which has been shown, in turn, to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares. It is also known that mind-body intervention reduces stress. The mind-gut connection is widely discussed in medical circles, however, current therapies have not capitalized on it. The investigators would like to know if an easily accessible mind-body intervention (yoga) can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with IBD.
The study will be an 8-week feasibility pilot. Participants will be asked to participate in online yoga videos and in-studio yoga sessions. Participants will be asked to complete multiple surveys throughout the intervention and continue receiving standard care from their primary gastroenterology team.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 10-21
- Diagnosis of Crohn's Disease or Ulcerative Colitis
- Patient of a Stanford Children's Health or Stanford-affiliated Pediatric Gastroenterologist
- Ability to attend in-person meetings/training
Key exclusion criteria (8 listed)
- Initiation of biologic therapy in prior 3 months
- Hospital admission in prior 2 months
- Major surgery in prior 1 month
- PUCAI/PCDAI >65
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions. | Behavioural | – |
Primary outcome
Assessment of acceptability
Time frame: 1 hour focus group at conclusion of intervention.
Focus Group
3 secondary outcomes
Fecal Calprotectin
Time frame: 6 weeks (Prior to intervention; After conclusion of intervention)
Pediatric Ulcerative Colitis Activity Index
Time frame: 6 weeks (Prior to intervention; After conclusion of intervention)
PROMIS-37
Time frame: 6 weeks (Prior to intervention; After conclusion of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Ming Yeh, MD principal investigator
Clinician Educator at Stanford University
Jenna Marie Arruda, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Inflammatory Bowel Diseases and Yoga, run by Stanford University at 1 site 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Assessment of acceptability (time frame: 1 hour focus group at conclusion of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2021.