Researchers are looking at the effects of a cannabidiol medication on stomach function in people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach caused by improper functioning of the stomach's muscles or nerves).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days. In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued.
Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days. In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Gastric Emptying Half-time (T1/2) of Solids
Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Gastric emptying (GE t 1/2) was measured by scintigraphy and defined as the time required for 50% of the radiolabeled tracer to empty from the stomach.
Time frame: 4 weeks
Gastric Emptying Lag Time (T-lag) of Solids
Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Gastric emptying lag time (GE t-lag) was measured by scintigraphy and defined as the amount of time the radioactive meal was in the stomach before starting to empty into the small bowel.
Time frame: 4 weeks
Fasting Gastric Volume
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).
Time frame: 4 weeks
Gastric Accommodation
Gastric accommodation 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).
Time frame: 4 weeks
Satiation Volume to Fullness
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. Participants recorded their sensations every 5 minutes using a numeric scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the MTV (maximum or unbearable fullness/satiation). Nutrient intake was stopped when subjects reach a score of 5.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 weeks
Satiation Maximum Tolerated Volume (MTV)
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. Participants recorded their sensations every 5 minutes using a numeric scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the MTV (maximum or unbearable fullness/satiation). Nutrient intake was stopped when subjects reach a score of 5.
Time frame: 4 weeks
Weekly Global Symptom Assessment
The number of functional dyspepsia participants who confirmed adequate relief of dyspepsia symptoms, based on the self-reporting question "In the past 7 days have you had adequate relief of your upper abdominal pain or discomfort?".
Time frame: 4 weeks
Mean Daily Symptom Score in Functional Dyspepsia
Self-reported daily symptom diaries assessed 3 symptoms of functional dyspepsia: (1) upper abdominal pain, (2) nausea, and (3) bloating or distension. Each symptom was scored from 0-4, where 0=none, 1= very mild, 2=mild, 3=moderate, and 4=severe. The responses were averaged together to provide an overall symptom score, which ranged from 0-4, where a higher score reflects worse symptoms.
Time frame: 4 weeks
Mean Daily Epigastric Pain in Functional Dyspepsia
Mean daily epigastric pain in functional dyspepsia participants as measured by the question "How much did you suffer from pain in your stomach area today?". The score is based on 5 point scale ranging from 0 (not at all) to 5 (extremely) where a higher score reflects more pain.
Time frame: 4 weeks
Quality of Life in Functional Dyspepsia
The Nepean Dyspepsia Index (NDI) is used to assess functional dyspepsia quality of life. NDI scores are summarized as overall quality of life based on 5 subscales: interference, knowledge/control, eating/drinking, sleep disturbance, work/study. There are two questions per subscale for a total of 10 questions. Each question is ranked from 0-4, where 0 is 'not at all' and 4 is 'extremely'. The results from each question are added together to generate a total index score of 0 to 40. A lower score reflects no to little impact functional dyspepsia has on on quality of life while a higher score reflects significant impact functional dyspepsia has on quality of life.
Time frame: 4 weeks
Aggregate Symptom Score
Postprandial symptoms of fullness, nausea, bloating, and pain were measured 30min after the satiation drink test using 100mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. Scores for each symptom were added to calculate the aggregate symptom score, which ranged from 0-400, where a lower score reflected mild symptoms and a higher score reflected more severe symptoms.
Time frame: 4 weeks
Overall Severity in Gastroparesis
Overall severity in gastroparesis was self-measured daily by asking the question "In thinking about your gastroparesis disorder, what was the overall severity of your gastroparesis symptoms today (during the past 24 hours)"? The responses were ranked as 0 (none), 1 (mild), 2 (moderate), 3 (severe) and 4 (very severe). Scores range from 0-4, where 0 reflects little to no severity of symptoms and 4 reflects severe symptoms.
Time frame: 4 weeks
Average Daily Vomiting Episodes in Gastroparesis
The average daily number of vomiting episodes in gastroparesis was measured by participants self-reporting responses to the question "In the past 24 hours how many episodes of vomiting did you have?"
Time frame: 4 weeks