Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children with Functional Abdominal Pain
功能性腹痛儿童的薄荷油药代动力学/动力学和新的生物特征
基本信息
- 批准号:10015202
- 负责人:
- 金额:$ 21.51万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-15 至 2022-09-14
- 项目状态:已结题
- 来源:
- 关键词:AbdomenAbdominal PainAddressAdultAffectAnimalsAntiinflammatory EffectBacteriaBiologicalBiological AvailabilityBiological MarkersBotanicalsCNS processingChildChildhoodChromograninsChronicChronic DiseaseCivilizationClinicalClinical ResearchClinical TrialsCommunitiesDataDevelopmentDietary CarbohydratesDiseaseDisease ManagementDistressDoseDrug KineticsEconomic BurdenEconomicsEffectivenessEmotionalFecesFrequenciesFunctional disorderGenerationsGenotypeGenus MenthaGoalsGut MucosaHealthHealth BenefitHumanHypersensitivityImmuneImmune SeraImmunologic MarkersIn VitroIndividualInternationalIrritable Bowel SyndromeIrritantsKineticsLinkLymphocyteMeasuresMentholMethodologyMucositisMucous MembraneMuscle relaxation phaseNatural ProductsOutcomePainPatient Outcomes AssessmentsPatternPeppermint oilPermeabilityPharmacodynamicsPhased Innovation AwardsPhenotypePhysiological ProcessesPhysiologyPlayQuality of lifeQuestionnairesResearch PriorityRoleSafetySample SizeSchool-Age PopulationSmooth MuscleSymptomsTimeUGT2B7 UDP-glucuronosyltransferaseVisceralVulnerable Populationsbasebeta-Defensinscell motilityconditioned pain modulationcytokinedesigndiariesdysbiosiseffective therapygastrointestinalgastrointestinal functiongenetic variantgut bacteriagut microbiomeimprovedindividualized medicineinflammatory disease of the intestineinnovationinsightmicrobiome compositionmultidisciplinarynovelpain processingpain symptompre-clinicalpsychosocialpublic health relevanceresearch clinical testingresponseside effectsocialtranscriptome sequencingtreatment strategy
项目摘要
DESCRIPTION (provided by applicant): Functional abdominal pain (FAP) affects 10-15% of children and adults worldwide and is characterized by chronic, intermittent abdominal pain. Symptoms range from mild to severe and debilitating and result in reduced quality of life. Up to 66% of children go on to have similar symptoms as adults. There are few effective treatments because of poor understanding of their mechanism of action (biological signatures) and of the pathophysiology of what are phenotypically and arbitrarily defined disorders. This R21/R33 application proposes to investigate the pharmaco-dynamic/kinetics (PKD) of peppermint oil (PMO), a botanical with some evidence of efficacy in adults with irritable bowel syndrome – a condition similar to FAP. We propose to study the PKD-gastrointestinal (GI) function relationships in children with FAP to link GI responses to PMO PKD, providing bioavailability data to be used to optimize dosing for a particular biological signature response, ultimately benefiting treatment and management of this disorder. No matter the outcome, our proposed study will provide an innovative and significant opportunity to develop novel data about the pathophysiology of FAP by investigating a number of biomarkers simultaneously in the same individual using cutting edge methodology to characterize gut microbiome composition and gut function in FAP. Our Specific Aims are to: R21, Aim 1 - Determine the PKD of PMO (menthol) in children with FAP (n=30). Hypothesis - a relationship exists between intraluminal/systemic menthol exposure and GI function. Sub-Hypothesis – Systemic menthol exposure after PMO reflects a genotype-phenotype relationship in subjects with allelic variants of CYP2A6 and/or UGT2B7. Aim 2 – Determine effect of PMO administration on gut microbiome composition (16S RNA sequencing) and contractile activity/gut transit rate (using the SmartPill®). Hypothesis – PMO will increase gut diversity and decrease contractile activity and gut transit. R33, Aim 1 - Confirm the findings of the R21 in a larger sample size and adjust dosing if necessary to optimize tolerability/safety and beneficial effects on gut microbiome composition and motility. Hypothesis: The findings of the R21 will be confirmed in the larger sample size. Treatment will be given for 1 week. Aim 2 – Assess the effect of PMO on pain processing (conditioned pain modulation), gut inflammation (stool beta defensin and chromogranin concentrations), and barrier function (permeability). Hypothesis: PMO will reduce visceral hypersensitivity, gut inflammation, and/or improve gut barrier function. Aim 3 - Evaluate the effect of PMO on clinical symptoms, psychosocial distress/patient reported outcomes, and acceptability (abdominal pain and stooling pattern via validated diary, pediatric PROMIS measures, side effects questionnaire). Hypothesis: PMO treatment will reduce abdominal pain frequency and patient reported outcomes will reflect this improvement.
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Robert J Shulman其他文献
IN VITRO UTILIZATION OF LACTOSE BY THE FECAL FLORA DIFFERS IN BREAST-(BR) AND BOTTLE-FED (BO) INFANTS
体外粪便菌群对乳糖的利用在母乳喂养(BR)和配方奶喂养(BO)婴儿中有所不同
- DOI:
10.1203/00006450-198704010-00630 - 发表时间:
1987-04-01 - 期刊:
- 影响因子:3.100
- 作者:
Carlos H Liischitz;May Chen;Robert J Shulman;Meyer Wolin;Buford L Nichols - 通讯作者:
Buford L Nichols
EFFECT OF FEEDING REGIMEN AND AMBIENT LIGHT EXPOSURE PATTERNS ON WEIGHT GAIN IN THE NEONATAL PIG. † 1873
- DOI:
10.1203/00006450-199604001-01897 - 发表时间:
1996-04-01 - 期刊:
- 影响因子:3.100
- 作者:
Lynn J Lotas;Robert J Shulman - 通讯作者:
Robert J Shulman
Mechanisms of Disease: update on the molecular etiology and fundamentals of parenteral nutrition associated cholestasis
疾病机制:肠外营养相关性胆汁淤积的分子病因学和基础研究的最新进展
- DOI:
10.1038/ncpgasthep0796 - 发表时间:
2007-05-01 - 期刊:
- 影响因子:51.000
- 作者:
Beth A Carter;Robert J Shulman - 通讯作者:
Robert J Shulman
The Addition of Human Milk Fortifier Does Not Affect Feeding Tolerance in Premature Infants † 1552
添加母乳强化剂不影响早产儿的喂养耐受性†1552
- DOI:
10.1203/00006450-199804001-01574 - 发表时间:
1998-04-01 - 期刊:
- 影响因子:3.100
- 作者:
Gloria J Moody;Richard J Schanler;Robert J Shulman;Chantal Lau - 通讯作者:
Chantal Lau
DEVELOPMENT OF HEPATIC N-DEMETHYLASE ACTIVITY AS MEASURED IN VIVO BY THE AMINOPYRINE BREATH TEST
通过氨基比林呼气试验在体内测量肝 N-去甲基酶活性的发展
- DOI:
10.1203/00006450-198404001-00404 - 发表时间:
1984-04-01 - 期刊:
- 影响因子:3.100
- 作者:
Robert J Shulman;Charles S Irving;Thomas W Boutton;William W Wong;Buford L Nichols;Peter D Klein - 通讯作者:
Peter D Klein
Robert J Shulman的其他文献
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{{ truncateString('Robert J Shulman', 18)}}的其他基金
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children with Functional Abdominal Pain
功能性腹痛儿童的薄荷油药代动力学/动力学和新的生物特征
- 批准号:
10001107 - 财政年份:2019
- 资助金额:
$ 21.51万 - 项目类别:
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children with Functional Abdominal Pain
功能性腹痛儿童的薄荷油药代动力学/动力学和新的生物特征
- 批准号:
10242085 - 财政年份:2019
- 资助金额:
$ 21.51万 - 项目类别:
Advancing Clinical Science in Pediatric Gastroparesis
推进小儿胃轻瘫的临床科学
- 批准号:
9564280 - 财政年份:2016
- 资助金额:
$ 21.51万 - 项目类别:
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children with Functional Abdominal Pain
功能性腹痛儿童的薄荷油药代动力学/动力学和新的生物特征
- 批准号:
9346618 - 财政年份:2016
- 资助金额:
$ 21.51万 - 项目类别:
Advancing Clinical Science in Pediatric Gastroparesis
推进小儿胃轻瘫的临床科学
- 批准号:
9554886 - 财政年份:2016
- 资助金额:
$ 21.51万 - 项目类别:
Advancing Clinical Science in Pediatric Gastroparesis
推进小儿胃轻瘫的临床科学
- 批准号:
10001460 - 财政年份:2016
- 资助金额:
$ 21.51万 - 项目类别:
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children with Functional Abdominal Pain
功能性腹痛儿童的薄荷油药代动力学/动力学和新的生物特征
- 批准号:
9096507 - 财政年份:2016
- 资助金额:
$ 21.51万 - 项目类别:
Genetic Analysis of Carbohydrate Maldigestion in Irritable Bowel Syndrome
肠易激综合征碳水化合物消化不良的遗传分析
- 批准号:
8901156 - 财政年份:2014
- 资助金额:
$ 21.51万 - 项目类别:
Genetic Analysis of Carbohydrate Maldigestion in Irritable Bowel Syndrome
肠易激综合征碳水化合物消化不良的遗传分析
- 批准号:
8701693 - 财政年份:2014
- 资助金额:
$ 21.51万 - 项目类别:
Pathways to New Biomarkers in Recurrent Abdominal Pain in Children
儿童复发性腹痛新生物标志物的途径
- 批准号:
8440046 - 财政年份:2012
- 资助金额:
$ 21.51万 - 项目类别:
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