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NCT04859829 · ClinicalTrials.gov registry record
Autoimmune Gastrointestinal Dysmotility: Symptoms, Pathogenesis and Treatment
A clinical trial, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- 1
- Enrollment target
NCT04859829: Clinical Trial study, sponsored by Johns Hopkins University.
NCT04859829 is a clinical trial that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04859829 was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
Autoimmune gastrointestinal dysmotility syndromes are poorly understood, and often difficult to treat because the underlying pathogenesis is unclear. Refractory symptoms result in an impaired quality of life. The presence of positive serum autoantibodies to peripheral nervous system gangliosides and glycoproteins is suggestive of a possible mechanism. Immunomodulator treatments have shown benefit in case reports and case series but standardized data for treatment response is lacking. Therefore, our primary aims are to further characterize this syndrome in terms of symptoms, laboratory testing, pathology, and assess treatment response of immunomodulator therapy. Our research plan involves identifying this subset of patients with autoimmune gastrointestinal dysmotility and dysautonomia, and studying them as they are managed by their gastroenterologists.The study team will administer symptom-based questionnaires in a systematic manner to assess the clinical trajectory of this population and treatment response. The investigators will also analyze laboratory values (antibody titers, tilt testing, inflammatory markers) and study pathology specimens (enteric and skin biopsies) obtained from this cohort to gain a deeper understanding of the pathogenesis of their disease.
Primary Outcome
The Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) is composed of 20 items and 6 sub-scales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Sub-scale scores are calculated by averaging across items comprising the sub-scale; scores vary from 0 (none or absent) to 5 (very severe).
Interventions
- OTHER Current Intravenous Immunoglobulin (IVIG) treatment
- OTHER No Intravenous Immunoglobulin (IVIG) treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2022-09-29 |
Why NCT04859829 stopped before completion
NCT04859829 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Current Intravenous Immunoglobulin (IVIG) treatment is the first listed.
NCT04859829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04859829 about?
NCT04859829 is a clinical study titled "Autoimmune Gastrointestinal Dysmotility: Symptoms, Pathogenesis and Treatment". Autoimmune gastrointestinal dysmotility syndromes are poorly understood, and often difficult to treat because the underlying pathogenesis is unclear. Refractory symptoms result in an impaired quality of life. The presence of positive serum autoantibodies to peripheral nervous system gangliosides and...
What is the current status of trial NCT04859829?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2021-04-22. Estimated completion is 2022-09-29.
What interventions are being tested in trial NCT04859829?
The interventions under investigation include: Current Intravenous Immunoglobulin (IVIG) treatment (OTHER), No Intravenous Immunoglobulin (IVIG) treatment (OTHER).
Who is sponsoring clinical trial NCT04859829?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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