How three ice-cream formulations affect esophageal movement in people with GERD or weak esophageal motility

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants undergo high-resolution esophageal manometry following the Chicago IV protocol to measure esophageal motility. During the procedure each person receives three different food products in a randomized order: a standard ice-cream sundae, an ice cream containing brazzein with maltitol and oligofructose, and an ice cream containing brazzein with erythritol, maltitol and inulin. Tolerability and symptoms after each product are recorded using standardized scales and formal questionnaires. The study compares motility patterns and patient-reported tolerability across the three formulations.

Why it matters

Who can join: the full rules

Inclusion 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 insulin.
* no new medications during participation in the study

Exclusion Criteria:

* 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, tranquilizers, prokinetic agents)
* 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.

Where it's running

• Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Sergey Morozov, MD, PhD — Federal Research Center of Nutrition and Biotechnology
• Study coordinator: Sergey Morozov, MD, PhD
• Email: 84996131091@mail.ru
• Phone: 4996131091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Quality sleep improvement with evening topical therapy for nocturnal GERD

  This trial tests a medical device given before bed to see if it reduces nighttime GERD symptoms and improves sleep and quality of life in adults with nocturnal reflux.

  Recruiting Cellmedis · Warsaw, Masovian Voivodeship and 1 other locations · NCT07700342

• Gerd symptoms with tegoprazan treatment in adults

  This study tests whether tegoprazan 50 mg (tablet or dispersible tablet) helps GERD symptoms and is safe in adults who meet criteria.

  Recruiting HK inno.N Corporation · Seoul · NCT07678177

• New topical treatment options for GERD symptoms

  This trial tests a medical device to see if it relieves GERD symptoms and improves quality of life in adults compared with a placebo.

  Recruiting Cellmedis · Warsaw, Masovian Voivodeship · NCT07624383

• Left-sided versus traditional bilateral laparoscopic repair for hiatal hernia with reflux

  This compares two laparoscopic operations—a left-sided approach and the traditional bilateral approach—to see which helps adults (18–85) with hiatal hernia whose reflux doesn't get better on usual acid‑reducing medicine.

  Recruiting Beijing Friendship Hospital · Beijing and 1 other locations · NCT07252115

• Improving GERD medication adherence using the GERDCare smartphone app

  This project will test whether the GERDCare smartphone app helps adults with GERD stick to their medications, diet, and lifestyle changes over four weeks.

  Recruiting Institute of Gastroenterology and Hepatology, Vietnam · Hanoi · NCT07125521

• Normal 24-hour esophageal pH‑impedance values in healthy Indian adults

  This project will measure 24-hour esophageal pH‑impedance readings, including acid exposure time, in healthy Indian adults to see what normal values are.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT06928350

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.