Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Secretin in Functional Dyspepsia and Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617861
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Michael Camilleri, MD, Mayo Clinic

Brief Summary:
Insights into the pathophysiology of functional dyspepsia, with recent demonstration of inflammation with eosinophilia and mastocytosis in the duodenum (3, 6, 7), providing a possible lead toward reduced secretion of a potential mediator of post-prandial gastric accommodation, the gastrointestinal peptide hormone secretin. The dominant site of synthesis and secretion of this hormone are enteroendocrine S cells in the duodenum. Inflammation-induced damage to these cells could produce a deficiency. Since intraluminal acid is a prominent stimulant of S cell secretion, the attempts to treat functional dyspepsia with anti-secretory medications could actually exacerbate a secretin deficiency syndrome. This raises the possibility of the therapeutic use of a secretin agonist or a positive allosteric modulator of the secretin receptor for patients with functional dyspepsia.

Condition or disease Intervention/treatment Phase
Dyspepsia Healthy Drug: Human Secretin Drug: Placebo Phase 1 Phase 2

Detailed Description:
The investigators will utilize single photon emission computed tomography (SPECT) methodology and gamma scintigraphy present in the GI laboratory of the outpatient Clinical Research Unit to study fasting gastric volumes and postprandial gastric accommodation responses and gastric emptying rates of a standardized meal in patients with functional dyspepsia and healthy subjects. Both groups will be studied twice, using crossover design, once with administration of secretin and once with placebo.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Blinded
Primary Purpose: Treatment
Official Title: Effect of Secretin on Gastric Accommodation, Emptying and Post-nutrient Challenge Symptoms in Functional Dyspepsia and Healthy Subjects
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Healthy Controls: Secretin Then Placebo
Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 2.
Drug: Human Secretin
Injected once over one minute
Other Name: ChiRhoStim

Drug: Placebo
Injected once over one minute
Other Name: Normal Saline

Experimental: Healthy Controls: Placebo Then Secretin
Healthy subjects first receive placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
Drug: Human Secretin
Injected once over one minute
Other Name: ChiRhoStim

Drug: Placebo
Injected once over one minute
Other Name: Normal Saline

Experimental: Functional Dyspepsia: Secretin Then Placebo
Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 2.
Drug: Human Secretin
Injected once over one minute
Other Name: ChiRhoStim

Drug: Placebo
Injected once over one minute
Other Name: Normal Saline

Experimental: Functional Dyspepsia: Placebo Then Secretin
Functional Dyspepsia subjects first receive placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
Drug: Human Secretin
Injected once over one minute
Other Name: ChiRhoStim

Drug: Placebo
Injected once over one minute
Other Name: Normal Saline




Primary Outcome Measures :
  1. Maximum Satiation [ Time Frame: 60 minutes ]
    Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.

  2. Fasting Gastric Volume [ Time Frame: Baseline ]
    Gastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).

  3. Postprandial Volume [ Time Frame: 15 minutes ]
    Postprandial volume was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).

  4. Change in Gastric Accommodation [ Time Frame: Baseline, 30 minutes ]
    The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.

  5. Gastric Emptying [ Time Frame: 30 minutes ]
    Gastric emptying was measured via scintigraphy 30 minutes after ingestion of 300 mL of radio-labeled Ensure drink and was reported as the percentage of the radio-labeled liquid meal emptied from the stomach.

  6. Change in Postprandial Symptoms [ Time Frame: Baseline, 30 minutes ]
    30 minutes after ingesting a meal of 300 mL of Ensure drink postprandial symptoms of fullness, nausea, bloating and pain were measured using a horizontal visual analog scales from 0 to 100, where 0 was 'none' and 100 was 'worst ever'.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patients with FD and prior documentation of normal or accelerated gastric emptying and/or reduced gastric accommodation.

Inclusion criteria:

  • Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures
  • No medical problems or chronic diseases, other than functional dyspepsia, for that group
  • Body mass index of 18-35 kg/m2
  • Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)].

Exclusion criteria:

  • Unable or unwilling to provide informed consent or to comply with study procedures
  • Diagnosis of other gastrointestinal diseases besides functional dyspepsia
  • Structural or metabolic diseases that affect the GI system
  • Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:

    • Medications that alter GI transit or motor function including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, buspirone, clonidine, tricyclic antidepressants, and secretin-norepinephrine reuptake inhibitors
    • Analgesic drugs including NSAIDs and COX-2 inhibitors
    • NOTE: Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardio-protection, low stable dose antidepressants of the SSRI class, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted) are permissible.
  • History of recent surgery (within 60 days of screening)
  • Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
  • Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator
  • Acute GI illness within 48 hours of initiation of the baseline period
  • Females who are pregnant or breastfeeding
  • History of excessive alcohol use or substance abuse
  • Participation in an investigational study within the 30 days prior to dosing in the present study
  • Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617861


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Michael Camilleri Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Michael Camilleri, MD, Mayo Clinic:
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Michael Camilleri, MD, Professor and Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03617861    
Other Study ID Numbers: 18-003744
R01DK115950 ( U.S. NIH Grant/Contract )
R01DK122280 ( U.S. NIH Grant/Contract )
UL1TR002377 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2018    Key Record Dates
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspepsia
Signs and Symptoms, Digestive
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs