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New treatment option for Ineffective Esophageal Motility
Official title The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility
ClinicalTrials.gov ID: NCT07121803
What this study is testing
- What it's testing
- This study aims to assess the influence of specialized products based on ice cream on esophageal motility
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- willingness to participate based on signed written informed consent;
- controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met:
- no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);
- doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium/glucose...
- no new medications during participation in the study
You likely can't join if
- Pregnancy and breastfeeding;
- Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM \> or = 14 kPa by Fibroscan), or APRI \> or= 1; or BARD score \> or = 2.
- Diarrhea of any type (watery stool more than 3 times a day).
- Chronic heart failure (I-IV class by NYHA).
- Past major abdominal or chest surgery, including bariatric procedures and fundoplication (except appendectomy or cholecystectomy performed more than...
- Achalasia and esophago-gastric junction outflow obstruction
See the full eligibility criteria
- willingness to participate based on signed written informed consent;
- controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met:
- no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);
- doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium/glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 agonists (GLP-1) or...
- no new medications during participation in the study
- Pregnancy and breastfeeding;
- Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM \> or = 14 kPa by Fibroscan), or APRI \> or= 1; or BARD score \> or = 2.
- Diarrhea of any type (watery stool more than 3 times a day).
- Chronic heart failure (I-IV class by NYHA).
- Past major abdominal or chest surgery, including bariatric procedures and fundoplication (except appendectomy or cholecystectomy performed more than a year before enrollment).
- Achalasia and esophago-gastric junction outflow obstruction
- Major esophageal motility disorders according to Chicago IV classification.
- Clinically relevant acute cardiovascular event within 6 months prior to screening.
- Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.
- Diabetes mellitus type 1.
- The level of glycated hemoglobin [HbA1c] \>9.0%.
- Hypersensitivity to the studied product or any of its components, including lactose intolerance.
- The intake of any pharmaceutical agents with known influence on esophageal motility (including, but not limited to: beta-blockers, calcium channel blockers, m-cholinoblockers, myorelaxants, antidepressants...
- Any medical conditions that may significantly affect life expectancy, including known cancers;
- Any clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, tumor or psychiatric diseases;
- Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with the requirements of the study protocol;
- Inability to tolerate high-resolution esophageal manometry without sedation, at least in part.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.