Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 685
- 试验地点
- 5
- 主要终点
- BSGM pediatric reference ranges in healthy controls.
研究概览
简要总结
The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.
详细描述
This is an prospective, multi-cohort study that will focus on adaptation and optimization of a novel non-invasive device called 'Body Surface Gastric Mapping (BSGM)' for use in children including defining and optimizing normal ranges in healthy children, defining abnormal patterns in children with GI symptoms, comparing BSGM patterns with currently used diagnostic tests, and evaluating the mechanisms behind current therapeutic interventions using BSGM patterns as biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age 8 to 25 years.
- •Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
- •Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:
- •Colonic Manometry
- •Pyloric Botox
- •Pyloric Dilation
- •Gastric Scintigraphy
- •Those with a body mass index of <
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
排除标准
- •History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)
- •Pregnant women.
- •Those with any condition, where fasting is not recommended by a physician.
- •Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
- •Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
- •Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
- •Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Inclusion Criteria for Controls
- •Males or females age 8 to 25 years.
- •Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
- •Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.
- •Those with a body mass index of <
- •Individuals may include siblings of those with FGIDs.
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
- •Exclusion Criteria for Controls
- •History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
- •Pregnant women.
- •Those with any condition, where fasting is not recommended by a physician.
- •Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
- •Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
- •Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
- •Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
研究组 & 干预措施
Children with functional GI disorders
干预措施: Body surface gastric mapping device (Device)
Healthy controls
干预措施: Body surface gastric mapping device (Device)
结局指标
主要结局
BSGM pediatric reference ranges in healthy controls.
时间窗: 30 minutes before the meal and 4 hours after having meal.
Healthy children will be recruited to provide BSGM reference range data. Control data will be used to compute normative data ranges for each key BSGM metric before and after the test meal: slow wave direction, pattern, velocity, frequency, and amplitude. For reference ranges: * BMI-adjusted amplitude: normal reference range at 5-95% CI * Rhythm-Index: normal reference range with cutoff \<5% CI * Frequency: 5-95% CI * Fed: fasted amplitude ratio: \<5% CI * Slow wave pattern: descriptive These outcomes will be measured via the myoelectric activity picked up by the BSGM device.
次要结局
- Functional disability: Functional disability will be measured by child-reported responses to questions on the Functional Disability Inventory (FDI).(30 minutes before the meal and 4 hours after having meal.)
- Abnormal BSGM patterns in participants with functional GI disorders.(30 minutes before the meal and 4 hours after having meal.)
- Nausea Severity(30 minutes before the meal and 4 hours after having meal.)
- Quality of life - Pediatric Quality of Life Modules(30 minutes before the meal and 4 hours after having meal.)
- Compare pediatric BSGM patterns with gastric scintigraphy, a reference diagnostic test.(30 minutes before the meal and 4 hours after having meal.)
- Changes in BSGM patterns after percutaneous electrical nerve field stimulation (PENFS).(30 minutes before the meal and 4 hours after having meal.)
- Changes in BSGM patterns after pyloric Botulinum toxin (Botox) injection.(30 minutes before the meal and 4 hours after having meal.)
- Correlation Model Parameters(1 hour before the meal and 4 hours after having meal.)
- Quality of Life - PROMIS-25 Instrument(30 minutes before the meal and 4 hours after having meal.)
- Compare Colonic Motor Patterns(1 hour before the meal and 4 hours after having meal.)
- Abdominal Pain Severity(30 minutes before the meal and 4 hours after having meal.)
- Quality of Life - PAGI-QoL(30 minutes before the meal and 4 hours after having meal.)
- Compare BSGM metrics with the antroduodenal manometry (ADM) metrics.(30 minutes before the meal and 4 hours after having meal.)
- Changes in BSGM patterns after heart rate variability biofeedback (HRVB) sessions.(Baseline visit before HRVB and two weeks after HRVB.])
- Changes in BSGM patterns after placement of a gastric electrical stimulator (GES).(30 minutes before the meal and 4 hours after having meal.)