StressNCT01736280
Evaluating and Treating Potential Research Participants With Digestive Disorders
A study of Stress and Irritable Bowel Syndrome, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
Background: Some research studies focus on digestive disorders, such as nutritional, gastrointestinal, and liver disorders. Researchers want to examine and treat people with digestive disorders in order to learn more about these disorders. They also want to study how digestive disorders run in some families. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Irritable Bowel Syndrome, Obesity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2012to 21 Nov 2019
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- This protocol will include participants from birth and has no upper age limit.
- Participants will be eligible if they:
- Have either a digestive disorder, OR
- Are an unaffected first-degree relative ( >2 years old) of a participant with a digestive disorder.
Who cannot join
- Participants will not be eligible if they:
- Are unwilling to give informed consent or, if a minor, do not have a parent or guardian able to provide consent, cannot assign a Durable Power of Attorney (DPA) or if a minor, do not have a parent or guardian able to provide consent.
- Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.
- NINR employees, subordinates/relatives/ or co-workers
- Any NIH employess who is a subordinate/relative/or co-worker of a study investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation and Treatment Protocol for Potential Research Participants With Digestive Disorders
Background:
- Some research studies focus on digestive disorders, such as nutritional, gastrointestinal, and liver disorders. Researchers want to examine and treat people with digestive disorders in order to learn more about these disorders. They also want to study how digestive disorders run in some families. To do so, they will provide standard care to people with digestive disorders. They will also look at relatives of people with digestive disorders, such as parents, children, and siblings.
Read more
Objectives:
- To examine and treat people with digestive disorders.
- To evaluate people with digestive disorders for research studies.
Eligibility:
- Individuals of any age who have digestive disorders.
- Individuals at least 2 years of age who are first-degree relatives of the people with digestive disorders.
Design:
- Participants will have at least one outpatient visit to the National Institutes of Health. The visit will last about 2 hours.
- All participants will be screened with a physical exam and medical history. They will also provide different samples for study. Samples may include blood, urine, and stool samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may be collected from adult participants.
- Participants with digestive disorders may be able to receive treatment through this study.
Read the detailed description
The National Institute of Nursing Research (NINR) is conducting a protocol to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed digestive conditions. Investigators of this protocol provide GI consultation at the NIH Clinical Center for a range of GI conditions.
Objectives: The primary objective of this protocol is to allow digestive care specialists in NINR and other institutions to provide standard of care. Evaluating and treating participants will allow digestive care specialists to maintain their expertise and gain additional knowledge of the course of various digestive disorders. Additionally this protocol will allow for hypothesis generation and provide a resource of patients for enrollment into new research protocols throughout the NINR branches. The information obtained will allow for the evaluation of standard treatments of the studied digestive diseases. This understanding may lead to ideas for future protocols. The protocol will also allow for trainees to receive training in the management of digestive disorders.
Study Population: The number of participants for this evaluation and treatment protocol will be set to 500 patients with digestive disorders and their unaffected first-degree relatives.
Design: This is a natural history evaluation and treatment protocol of the progression and physiology of multiple digestive disorders. Blood or other biologic samples (including but not limited to stool, urine, saliva, hair, cheek swab, or tissue) will be obtained through non-invasive means or incidentally to clinical care for future laboratory studies. In addition, genetic samples may be collected from unaffected first-degree relatives and may be used to identify and verify causative mutations.
Outcome Measures: The outcome measures for this protocol are the clinical assessments of enrolled participants, including their response to standard treatments. Also, causative mutations may help establish pathogenic mechanisms and genotype-phenotype correlations.
- Conditions
- Stress, Irritable Bowel Syndrome, Obesity, Abdominal Pain
- Being tested
- Standard of Care
- Keywords
- Symptoms, Immunogenetics, Digestive Disorders, Gastrointestinal
- Medical subject headings
- Irritable Bowel Syndrome, Obesity, Abdominal Pain, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Any evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Standard of Care. Participants will be evaluated and treated for their particular digestive disorder or presenting symptoms. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation and treatment of GI disorders
This protocol allows NINR investigators to provide treatment for GI disorders and maintain knowledge and expertise of GI disorders.
Measured: Outcomes will be assessed periodically according to disorder and severity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study start17 Sep 2012
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wendy A Henderson, C.R.N.P., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736280
- Sponsor's protocol ID
- 120195
- Other IDs
- 12-NR-0195
- Status last verified
- 21 Nov 2019
- First submitted
- 27 Nov 2012
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment Protocol for Potential Research Participants With Digestive Disorders
- ClinicalTrials.gov ID
- NCT01736280
- Acronym / sponsor ID
- 120195
- Conditions
- Stress, Irritable Bowel Syndrome, Obesity, Abdominal Pain
- Keywords
- Symptoms, Immunogenetics, Digestive Disorders, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 17 Sep 2012
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 29 Nov 2012 (estimated)
- 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.
Background:
- Some research studies focus on digestive disorders, such as nutritional, gastrointestinal, and liver disorders. Researchers want to examine and treat people with digestive disorders in order to learn more about these disorders. They also want to study how digestive disorders run in some families. To do so, they will provide standard care to people with digestive disorders. They will also look at relatives of people with digestive disorders, such as parents, children, and siblings.
Objectives:
- To examine and treat people with digestive disorders.
- To evaluate people with digestive disorders for research studies.
Eligibility:
- Individuals of any age who have digestive disorders.
- Individuals at least 2 years of age who are first-degree relatives of the people with digestive disorders.
Design:
- Participants will have at least one outpatient visit to the National Institutes of Health. The visit will last about 2 hours.
- All participants will be screened with a physical exam and medical history. They will also provide different samples for study. Samples may include blood, urine, and stool samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may be collected from adult participants.
- Participants with digestive disorders may be able to receive treatment through this study.
Detailed description
The National Institute of Nursing Research (NINR) is conducting a protocol to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed digestive conditions. Investigators of this protocol provide GI consultation at the NIH Clinical Center for a range of GI conditions.
Objectives: The primary objective of this protocol is to allow digestive care specialists in NINR and other institutions to provide standard of care. Evaluating and treating participants will allow digestive care specialists to maintain their expertise and gain additional knowledge of the course of various digestive disorders. Additionally this protocol will allow for hypothesis generation and provide a resource of patients for enrollment into new research protocols throughout the NINR branches. The information obtained will allow for the evaluation of standard treatments of the studied digestive diseases. This understanding may lead to ideas for future protocols. The protocol will also allow for trainees to receive training in the management of digestive disorders.
Study Population: The number of participants for this evaluation and treatment protocol will be set to 500 patients with digestive disorders and their unaffected first-degree relatives.
Design: This is a natural history evaluation and treatment protocol of the progression and physiology of multiple digestive disorders. Blood or other biologic samples (including but not limited to stool, urine, saliva, hair, cheek swab, or tissue) will be obtained through non-invasive means or incidentally to clinical care for future laboratory studies. In addition, genetic samples may be collected from unaffected first-degree relatives and may be used to identify and verify causative mutations.
Outcome Measures: The outcome measures for this protocol are the clinical assessments of enrolled participants, including their response to standard treatments. Also, causative mutations may help establish pathogenic mechanisms and genotype-phenotype correlations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Standard of CareStandard of Care. Participants will be evaluated and treated for their particular digestive disorder or presenting symptoms. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- This protocol will include participants from birth and has no upper age limit.
- Have either a digestive disorder, OR
- Are an unaffected first-degree relative ( >2 years old) of a participant with a digestive disorder.
Key exclusion criteria (5 listed)
- Are unwilling to give informed consent or, if a minor, do not have a parent or guardian able to provide consent, cannot assign a Durable Power of Attorney (DPA) or if a minor, do not have a parent or guardian able to provide consent.
- Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.
- NINR employees, subordinates/relatives/ or co-workers
- Any NIH employess who is a subordinate/relative/or co-worker of a study investigator
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 |
|---|---|---|
| Standard of CareAny evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder. | Other | 1 |
Primary outcome
Evaluation and treatment of GI disorders
Time frame: Outcomes will be assessed periodically according to disorder and severity.
This protocol allows NINR investigators to provide treatment for GI disorders and maintain knowledge and expertise of GI disorders.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
Related trials for Stress
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Active, not recruiting
Aimmune Longitudinal Collaboration Study
Stool Spore Colony Forming Units, Microbiome Composition
Not yet recruiting
Robot-Assisted Meditation for Older Adults With Cognitive Concerns
Cognitive Impairment, Perceived Stress
Recruiting
Stress Modulation and Dynamic Balance
Stress
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
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.
Wendy A Henderson, C.R.N.P. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress and Irritable Bowel Syndrome, run by National Institute of Nursing Research (NINR) 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 5 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: stopped early, as of the sponsor's last update on 26 Nov 2019. 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 was stopped early. Results are not available in the source record.
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?
Evaluation and treatment of GI disorders (time frame: Outcomes will be assessed periodically according to disorder and severity.). 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 26 Nov 2019; AzTrials last refreshed its copy on 31 Oct 2026.