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Evaluating and Treating Potential Research Participants With Digestive Disorders

23 november 2019 bijgewerkt door: National Institute of Nursing Research (NINR)

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.

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

225

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  • INCLUSION CRITERIA:

This protocol will include participants from birth and has no upper age limit.

Participants will be eligible if they:

  1. Have either a digestive disorder, OR
  2. Are an unaffected first-degree relative ( >2 years old) of a participant with a digestive disorder.

EXCLUSION CRITERIA:<TAB>

Participants will not be eligible if they:

  1. 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.
  2. Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.
  3. NINR employees, subordinates/relatives/ or co-workers
  4. Any NIH employess who is a subordinate/relative/or co-worker of a study investigator

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 1
Standard of Care. Participants will be evaluated and treated for their particular digestive disorder or presenting symptoms.
Ander: Standard of Care
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation and treatment of GI disorders
Tijdsspanne: 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.
Outcomes will be assessed periodically according to disorder and severity.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Nursing Research (NINR)

Onderzoekers

  • Hoofdonderzoeker: Wendy A Henderson, C.R.N.P., National Institute of Nursing Research (NINR)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

17 september 2012

Primaire voltooiing (Werkelijk)

21 november 2019

Studie voltooiing (Werkelijk)

21 november 2019

Studieregistratiedata

Eerst ingediend

27 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

27 november 2012

Eerst geplaatst (Schatting)

29 november 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 november 2019

Laatste update ingediend die voldeed aan QC-criteria

23 november 2019

Laatst geverifieerd

21 november 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 120195
  • 12-NR-0195

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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