Treatment Trials

53 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Fiber Product for Gas, Bloating, and Bowel Regularity
Description

This is a new, commercially available, over-the-counter fiber supplement that combines 8 fibers. The varied nature of the fibers in this product is designed to create a more diverse microbiome (bacteria that live within the human GI tract). In general, the more diverse the microbiome the less inflammatory the gut. The purpose of this study is to evaluate the effects of a new fiber product on bloating, gas, and bowel movements.

RECRUITING
Diaphragmatic Breathing for the Treatment of Bloating and Distension
Description

The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.

Conditions
ACTIVE_NOT_RECRUITING
Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol
Description

The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.

Conditions
COMPLETED
Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
Description

Flatter Me is a product that includes digestive enzymes in a way to support digestion of macronutrients and their constituents and provides herbs traditionally used for digestive health support. This trial aims to test Flatter Me against a placebo pill to examine differences in both subjective outcomes (feelings of bloating and indigestion) and changes in waist circumference (abdominal distension) after eating a test meal.

NOT_YET_RECRUITING
Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis
Description

Gastrointestinal symptoms are commonly reported in as much as 65% of people with CF even independent of pancreatic enzyme replacement therapy (PERT) and the most frequent of these symptoms are bloating/distension, flatulence, abdominal pain and bowel habit changes. An alteration in the intestinal microbiome due to intestinal dysmotility, inflammation or other changes including pH changes in the intestine related to CFTR gene mutation may cause intestinal dysbiosis leading to a bacterial overgrowth in the proximal small intestine which may explain some of the findings of distension and bloating in CF. Our small pilot study aims to investigate use of the only FDA-approved antibiotic, rifaximin for a GI syndrome- IBS, to treat bloating and global GI symptoms in CF patients with bloating and distension. Our goal is to recruit patients \>12 years and age/sex matched into rifaximin and placebo arms with total of 100 recruited subjects recruited.

UNKNOWN
Assessment and Validation of Electronic Gas and Bloating Diary
Description

The investigator's goal is to improve the patient's compliance and accurate capture of patient reported gas and bloating symptoms, by utilizing a phone application that interactively records each gas and bloating event in addition to bowel events and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. The investigator will compare and validate the electronic gas and bloating diary with the paper gas and bloating diary.

COMPLETED
Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
Description

The prevalence of exocrine pancreatic insufficiency (EPI) among patients presenting with diarrhea and bloating as their chief complaints is not well studied. Diarrhea and or bloating can be due to different etiologies such as celiac disease and irritable bowel syndrome. However, concomitant EPI can exacerbate these conditions, or be the main cause of the symptoms. Furthermore, some of these diagnoses can be epiphenomena or consequences of EPI. The Investigators hypothesize that EPI will be detected in significant proportion of patients with bloating or diarrhea and that early detection and management of EPI can prevent unnecessary work up for other causes of diarrhea.

COMPLETED
A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
Description

The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise healthy adults.

Conditions
COMPLETED
Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating
Description

This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.

COMPLETED
Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms
Description

This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study. Study Primary Objective: • To assess improvement in bloating symptoms Study Secondary Objectives: * To assess safety and tolerability of the formulation * To compare the time taken for perceptual improvement in bloating/distention * Enzyme blood assays * To assess quality of life indices

Conditions
COMPLETED
A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.
Description

This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.

ACTIVE_NOT_RECRUITING
An Efficacy Trial in the Research Area of Gastrointestinal Health & Bloating
Description

A randomized, double-blinded, placebo-controlled, parallel study, to evaluate the effect of 8-week supplementation of a traditionally fermented organic coconut milk kefir compared to placebo on gastrointestinal symptoms in healthy adults.

COMPLETED
Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms
Description

This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).

COMPLETED
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
Description

The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily \[TID\]) as compared to placebo on abdominal bloating rating in female IBS patients.

COMPLETED
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
Description

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

COMPLETED
Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
Description

To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.

Conditions
COMPLETED
Efficacy of Pancrelipase on Postprandial Belching and Bloating.
Description

The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.

COMPLETED
A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health
Description

This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.

COMPLETED
Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects
Description

The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

COMPLETED
Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects
Description

The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

NOT_YET_RECRUITING
Visible Abdominal Distension
Description

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers. Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

RECRUITING
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
Description

We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.

COMPLETED
A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
Description

This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.

ACTIVE_NOT_RECRUITING
The Effects of Oral Fructanase Administration on Gastrointestinal Symptoms After Inulin Challenge in Healthy Adults
Description

The carbohydrate inulin (from chicory root) is a healthy prebiotic ingredient found in dietary supplements and fortified foods (Nagy et al). Inulin is representative of a broader class of typically health-associated, yet fermentable carbohydrates called fructans that occur naturally in many vegetables, fruits, and wheat. Fructans, or long chains of fructose units, are resistant to human digestive enzyme hydrolysis and transit intact to the small intestine and colon where they undergo rapid fermentation by intestinal microbes. This microbial metabolism of fructans produces gas and other fermentation byproducts that can lead to excess gastrointestinal (GI) symptoms like abdominal bloating, cramping, stomach rumbling, and flatulence (Bonnema et al; Briet et al; Bruhwyler et al), especially in individuals with irritable bowel syndrome (Van den Houte et al). A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption. Positive findings from in vitro digestion simulations (Guice et al) and a first-in-human safety trial (Garvey et al) helped define the fructanase dose for this clinical trial-the primary objective of which is to investigate the effect of oral fructanase administration on GI symptoms in healthy adults after consuming oatmeal with added inulin (25 grams). Secondary outcomes include breath hydrogen and methane levels, which serve as biomarkers of intestinal microbial fermentation. The investigators hypothesize that fructanase administration will lower the severity of GI symptoms after inulin consumption, as well as lower breath biomarkers of intestinal microbial fermentation, compared to placebo.

RECRUITING
Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
Description

The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms

Conditions
COMPLETED
The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults
Description

The primary objective of this study is to investigate the effect of an oral probiotic (Bacillus sp. spore preparation) on abdominal bloating, flatulence, and burping in generally healthy adults. Secondary outcomes include intestinal barrier integrity and fecal microbiome properties (taxonomical structure, diversity, and function).

RECRUITING
Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions
Description

US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.

COMPLETED
Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
Description

This exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion.

ENROLLING_BY_INVITATION
Indiana University Gastric Electrical Stimulation Registry
Description

The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

Conditions
COMPLETED
Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy Adults
Description

The primary objective of this study is to investigate the effect of a novel Bacillus subtilis spore preparation on abdominal bloating, flatulence, and burping in healthy adults.