The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Symptom Response
研究概览
简要总结
The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients.
The main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants?
If there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups.
Participants will be be asked to do the following:
- participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy
- take an oral capsule daily (omeprazole 40mg or placebo)
- come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider
- consider incorporating recommended lifestyle modifications
- complete weekly surveys
详细描述
This research study is being conducted to compare the efficacy between usual care and a novel mechanism guided strategy for adults with chronic throat (laryngeal) symptoms undergoing evaluation for laryngopharyngeal reflux (LPR).
Usual care strategy is used clinically and is known to reduce chronic throat symptoms. The mechanism guided strategy is a new treatment that personalizes the application of acid suppression medication and voice therapy to the patient. The mechanism guided strategy is being evaluated for how well it works in patients with these throat symptoms.
Participants who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) inclusive of an upper endoscopy with ambulatory pH monitoring (reflux testing) will be recruited for participation in this study.
Participants will undergo screening to confirm eligibility. Once informed consent is administered and signed, participants will be asked about their demographic background, current symptoms, brief medical history, and current medications. Screening takes place within 30 days of a participant's scheduled clinical upper endoscopy with reflux testing.
After completing the clinical upper endoscopy and reflux testing, they will be scheduled for their first intervention visit, about 1 week later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participant will not know which strategy group they are randomized to and they will not know which daily oral capsule (omeprazole 40mg or placebo) they have been dispensed. The study provider they meet with during intervention visits will not know the results of their upper endoscopy and reflux testing.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-89 years of age
- •>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)
- •Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression
- •Off acid suppression therapy for at least 2 weeks prior to randomization.
排除标准
- •PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles
- •History of foregut surgery
- •Known diagnosis of achalasia
- •Inability to fast for 4 hours (no food or drink)
- •Active tobacco use
- •Pregnant or breastfeeding
- •Unable to consent in English or Spanish
- •Unable to provide consent without a legal guardian or representative
- •Endoscopic findings conclusive with esophageal mucosal abnormalities
- •Unable to proceed with reflux monitoring
- •Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed
- •Prior LRT for reflux related symptoms
- •History of major psychiatric comorbidity
- •Unable to attend in person study visits at UCSD
研究组 & 干预措施
Mechanism Guided Strategy
- 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms.
- Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination.
- Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes.
- Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.
干预措施: Omeprazole 40 MG (Drug)
Mechanism Guided Strategy
- 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms.
- Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination.
- Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes.
- Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.
干预措施: Laryngeal Recalibration Therapy (Behavioral)
Mechanism Guided Strategy
- 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms.
- Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination.
- Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes.
- Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.
干预措施: GERD Lifestyle Recommendations (Behavioral)
Usual Care Strategy
- an 8-week course of double dose PPI and 2) lifestyle counseling. This represents the control group receiving usual care and will serve as the study's active control group. In order to maintain group concealment, subjects will receive counseling from a study investigator on standard lifestyle modifications recommended for GERD at intervals mirroring that of the mechanism guided strategy: week 1, week 4, and week 8 which is also reflective of standard recommended follow-up and counseling in GERD management.
干预措施: Omeprazole 40 MG (Drug)
Usual Care Strategy
- an 8-week course of double dose PPI and 2) lifestyle counseling. This represents the control group receiving usual care and will serve as the study's active control group. In order to maintain group concealment, subjects will receive counseling from a study investigator on standard lifestyle modifications recommended for GERD at intervals mirroring that of the mechanism guided strategy: week 1, week 4, and week 8 which is also reflective of standard recommended follow-up and counseling in GERD management.
干预措施: GERD Lifestyle Recommendations (Behavioral)
结局指标
主要结局
Symptom Response
时间窗: 5 years
Proportion of subjects with symptom response measured by the reflux symptom index (RSI) score.
次要结局
- Diagnostic Methods for LPR(5 years)
研究者
Rena Yadlapati
Professor of Medicine
University of California, San Diego