Chronic Indigestion

About Chronic Indigestion Clinical Trials (Click to Open)

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General Purpose:

Indigestion, or dyspepsia, simply refers to stomach discomfort. It is not a disease, but instead a grouping of symptoms that can include bloating, belching, and nausea. It is very common yet experienced in different ways by different individuals.

Symptoms include an early sense of fullness during a meal, uncomfortable fullness after a meal, abdominal pain, and abdominal burning. Nausea and a bloated feeling are also possible. Indigestion may also be accompanied by heartburn, which is a separate condition characterized by a sensation of pain or burning in the chest.

Indigestion can result from overeating, eating too fast, consuming fatty foods or foods cooked in grease, caffeine, alcohol, chocolate, carbonated beverages, smoking, nervousness and/or anxiety, emotional trauma, medications, pancreatitis (inflammation of the pancreas), gallstones, and stomach cancer.

A separate type of indigestion, known as functional dyspepsia, occurs when the stomach is unable to digest food adequately and then pass it into the small intestines. Lifestyle and behavioral changes – such as changing eating habits, portion sizes, and diet – can have a profound and positive impact on indigestion; however, sometimes these efforts are not sufficient and medication may be needed.

Antacids (such as AlkaSeltzer, Tums, and others) can help to neutralize stomach acid. Longer-acting medications include those in the H-2-receptor agonist (H2RA) group. Drugs such as these include Tagamet, Pepcid, and Zantac. For individuals who have indigestion in association with gastroesophageal reflux disease (GERD), proton pump inhibitors, such as Prevacid or Prilosec, may also be helpful.

Researchers are currently studying better ways of treating both dyspepsia and functional dyspepsia, as well as evaluating new diagnostic tools. Others are studying new medications to decrease stomach sensitivity, while others are working hard to gain a better understanding of how the digestive system works in relationship with the brain.

What Will Indigestion Clinical Trials Be Like?

The types of tests and assessments used in clinical trials for indigestion will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:

  • Upper GI series: a series of x-rays performed after an individual has fasted for a period of time and then consumed a chalky-tasting liquid that makes the stomach and intestines more visible on x-ray.
  • Upper gastrointestinal (GI) endoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is fed down the mouth or nose, through the esophagus, and into the stomach and first part of the small intestine.
  • Abdominal ultrasound
  • Computed tomography (CT, or “CAT scan”): an imaging procedure that uses an x-ray machine linked to a computer to take detailed pictures of areas inside the body.
  • Gastric emptying study: a test during which an individual eats food that contains a small amount of a radioactive material that allows doctors to measure how quickly food leaves the stomach.
  • You may be asked to take antacid medications, or refrain from taking antacid medications.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Indigestion Clinical Trial Protocol:

Specific examples of clinical trials for indigestion might include the following:

  • A randomized clinical trial to compare the effectiveness of two different antidepressant medications for the treatment of functional dyspepsia. Antidepressants are used for such treatment due to their ability to treat underlying anxiety disorders, as well as because they have pain-relieving properties. In such a study, patients with functional dyspepsia would be randomly assigned to receive treatment with one of two different antidepressant medications, or placebo.
  • An interventional study to determine if standard and investigational tests used to diagnose and treat food allergies in children are useful at providing information that can help determine the cause of dyspepsia in children. Such a study would require participants to undergo standard skin-prick allergy testing and blood tests.
  • A randomized clinical trial to determine if acupuncture is an effective method of treating functional dyspepsia among individuals between the ages of 18 and 50. In such a study, half of the patients would be randomly assigned to receive acupuncture, while the remaining half would be randomly assigned to receive a sham/placebo acupuncture-like procedure.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as in the first and third examples provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of indigestion
  • Any known triggers of your symptoms
  • Any underlying illnesses you have
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your history of treatment for indigestion

Suggested Search Terms:

Once you are ready to begin your search for indigestion clinical trials, the following terms may be of use when combined with “indigestion”: “prevention,” “management,” “treatment,” “diet,” “exercise,” “disease,” “medication,” “pregnancy,””diagnosis,” “pediatric,” and “children.”

You may also prefer to substitute the term “dyspepsia” for “indigestion” in your searches.

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Buspirone Plus Omeprazole for Functional Dyspepsia

Condition:   Dyspepsia
Interventions:   Drug: Buspirone;   Drug: Placebo Oral Tablet
Sponsor:   Isfahan University of Medical Sciences

Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy

Condition:   Dyspepsia
Interventions:   Procedure: gastroscopy;   Device: magnetic assisted capsule endoscopy
Sponsor:   Sheffield Teaching Hospitals NHS Foundation Trust

Health Related Quality of Life in Functional Dyspepsia

Condition:   Dyspepsia
Sponsor:   Indonesia University

Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia

Condition:   Functional Dyspepsia
Intervention:   Procedure: Gastroduodenoscopy
Sponsor:   Universitaire Ziekenhuizen Leuven

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Condition:   Functional Dyspepsia
Interventions:   Drug: UI05MSP015CT;   Drug: Gasmotin
Sponsor:   Korea United Pharm. Inc.

Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia

Conditions:   Dyspepsia;   Indigestion
Intervention:   Device: e-learning
Sponsors:   Radboud University;   ZonMw: The Netherlands Organisation for Health Research and Development;   Maastricht University Medical Center;   Canisius-Wilhelmina Hospital;   VieCuri Medical Centre
Enrolling by invitation

Sourdough Bakery Products and Digestive Function

Condition:   Dyspepsia
Interventions:   Dietary Supplement: Sourdough --> Brewer's Yeast;   Dietary Supplement: Brewer's Yeast --> Sourdough
Sponsors:   Irccs Sdn;   Federico II University;   Fresystem S.p.A.

Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)

Condition:   Functional Dyspepsia
Interventions:   Drug: DWJ1252;   Drug: Gasmotin;   Drug: Placebo of Gasmotin;   Drug: Placebo of DWJ1252
Sponsor:   Daewoong Pharmaceutical Co. LTD.

Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients

Condition:   Dyspepsia
Interventions:   Drug: Kolofort;   Drug: Placebo
Sponsor:   Materia Medica Holding

Treatment of Constipation in Functional Dyspepsia

Conditions:   Dyspepsia;   Constipation
Interventions:   Behavioral: Biofeedback;   Dietary Supplement: Fiber supplement
Sponsor:   Hospital Universitari Vall d'Hebron Research Institute

A Study to Evaluate the Effects of ABX-1431 on Patients With Functional Dyspepsia

Condition:   Dyspepsia
Interventions:   Drug: ABX-1431;   Drug: Placebo
Sponsor:   Abide Therapeutics

Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

Conditions:   Dyspepsia;   Dietary Modification
Interventions:   Behavioral: Low FODMAP Diet;   Behavioral: Choose My Plate Diet
Sponsor:   Advocate Health Care

Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients

Condition:   Functional Dyspepsia
Intervention:   Behavioral: visual images
Sponsor:   University Hospital Tuebingen

A Two Week Nitazoxanidebased Quadruple Regimen

Condition:   Dyspepsia
Interventions:   Drug: Nitazoxanide;   Drug: Levofloxacin;   Drug: Doxycyclin;   Drug: Omeprazole
Sponsor:   Tanta University

Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Condition:   Dyspepsia
Interventions:   Drug: FDC Bromopride 10 mg and Simethicone 80 mg;   Drug: Bromopride 10 mg
Sponsor:   EMS

Hedonic Perception and Brain Activity Response to Meal

Condition:   Dyspepsia
Interventions:   Device: Functional brain MRI;   Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice
Sponsor:   Hospital Universitari Vall d'Hebron Research Institute

The Effect and Mechanism of Acupuncture on Functional Dyspepsia

Condition:   Dyspepsia
Interventions:   Device: Acupuncture;   Device: Sham acupuncture
Sponsors:   Kyunghee University Medical Center;   Korea Institute of Oriental Medicine;   Kyung Hee University Hospital at Gangdong

Effect of Genetic Association With Functional Dyspepsia and Mood Disorders

Condition:   Dyspepsia
Sponsor:   Chinese University of Hong Kong

SSRI Study for Functional Dyspepsia (SS)

Conditions:   Dyspepsia;   Anxiety;   Depression
Interventions:   Drug: Escitalopram;   Other: Placebo
Sponsor:   Chinese University of Hong Kong

The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia

Condition:   Functional Dyspepsia
Interventions:   Drug: Rikkunshito;   Drug: Rikkunshito placebo
Sponsor:   Osaka City University

Phase III, Long-term, Open-label Safety Study of Z-338

Condition:   Dyspepsia
Intervention:   Drug: Z-338
Sponsor:   Zeria Pharmaceutical

BRAVO Study for Functional Dyspepsia

Conditions:   Dyspepsia;   Gastroesophageal Reflux
Interventions:   Drug: Esomeprazole 20mg;   Other: Placebo
Sponsor:   Chinese University of Hong Kong

Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

Condition:   Non Ulcer Dyspepsia
Interventions:   Drug: Nortriptyline;   Drug: Placebo
Sponsor:   The Cleveland Clinic

Helicobacter Eradication Relief of Dyspeptic Symptoms

Condition:   Functional Dyspepsia
Intervention:   Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days
Sponsors:   Hospital de Clinicas de Porto Alegre;   Aché Laboratórios Farmacêuticos Ltda

YM443 in Subjects With Functional Dyspepsia

Conditions:   Indigestion;   Nausea
Intervention:   Drug: YM443
Sponsors:   Astellas Pharma Inc;   Astellas Pharma US, Inc.

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