Lactose Intolerance

This research aims to evaluate the safety, tolerability, and nutrient absorption of the RELiZORB enzyme cartridge in children aged 2 to 18 years with Short Bowel Syndrome (SBS) who depend on parenteral nutrition (PN). SBS causes inadequate intestinal absorption due to significant loss of small bowel, requiring intravenous nutrition to maintain hydration and nutrition but leading to complications such as liver failure. The study explores whether predigesting fats with RELiZORB can improve absorption and reduce reliance on PN. The RELiZORB device is an enzyme cartridge connected to enteral feeding tubes that mimics pancreatic lipase to digest fats before they enter the gut, aiming to improve fat absorption without the need for bile acid emulsification. Participants will receive tube feeding through the device daily for 90 days. The study monitors changes in PN calories over time, along with growth, fecal fat, plasma fatty acids, and nutrition intake. Participants will be assessed at multiple time points during the 90-day treatment to evaluate PN calorie reduction and nutritional status. Safety and tolerability will be monitored by recording adverse events. The study involves regular clinical visits, laboratory tests, and nutrition assessments to measure the effectiveness of RELiZORB in improving enteral nutrition absorption and supporting growth while reducing PN dependence.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Hydrogen breath tests are used to detect carbohydrate malabsorption, measure the time it takes food to move through the intestines (oro-caecal transit time or OCTT), link hydrogen gas increases with abdominal symptoms like bloating and diarrhea, and diagnose small intestinal bacterial overgrowth (SIBO). Differentiating carbohydrate intolerance from SIBO is important because their treatments differ, with dietary changes used for intolerance and antibiotics for SIBO. Recent guidelines question the accuracy of hydrogen breath tests alone for diagnosing SIBO due to variable OCTT measurements, which can cause false positives. This study evaluates a new, simple, and affordable method combining a 20g lactulose hydrogen breath test with abdominal X-ray imaging to confirm OCTT and diagnose SIBO or carbohydrate intolerance. During the test, if hydrogen levels rise before the contrast agent appears in the cecum, SIBO is indicated. If the contrast agent is visible when hydrogen increases, OCTT is confirmed and symptoms after this point suggest carbohydrate intolerance. This approach aims to improve diagnosis without the higher costs and complexity of other imaging techniques. Participants included adults referred for hydrogen breath testing due to digestive symptoms with no organic disease found. During the test, breath hydrogen is monitored while abdominal X-rays are taken when hydrogen rises. Researchers will assess the safety and practicality of this combined test, measure agreement between observers analyzing OCTT, and determine the prevalence of food intolerance and SIBO among participants. The total assessment occurs within three hours during routine clinical care, using existing clinical data with patient consent.

Researchers are investigating whether the thickness of gastrostomy tubes affects the rate of postoperative complications in children who need long-term enteral nutrition. This study compares two tube sizes, 12 Fr and 14 Fr, to see if a smaller tube might reduce issues such as granuloma, infection, pain, dislocation, and leakage. Gastrostomy is a common procedure in children with conditions like neurological diseases and metabolic disorders, and the study aims to provide clearer guidance on tube size choice. Children scheduled for laparoscopic gastrostomy are randomly assigned to receive either a 12 Fr or 14 Fr gastrostomy tube. After surgery, the tubes are changed at three months following national guidelines. Both families and healthcare personnel complete questionnaires about any complications experienced during this period. The data collected will be analyzed to determine if tube size influences complication rates. Participants will have a gastrostomy placed and then return for a follow-up visit three months later when the tube is changed. During this visit, questionnaires about complications such as granuloma formation, infection, pain, dislocation, and leakage will be completed by nurses and caregivers. The study will collect and analyze this information to assess outcomes. Participation involves surgery, follow-up care, and data collection over a three-month postoperative period.

Researchers are studying the effects of acupuncture on people with mild to moderate active Crohn's disease. The study aims to see how acupuncture affects symptoms, brain activity, and the metabolism of certain substances (TRY-KYN) related to the brain-gut connection. They also want to identify brain imaging markers linked to acupuncture treatment in Crohn's disease. The study is led by the Shanghai Institute of Acupuncture, Moxibustion and Meridian. Participants will receive acupuncture and mild moxibustion treatments three times a week for 12 weeks. Specific points on the body (such as CV12, ST37, SP6, and others) will be used for acupuncture and moxibustion, with a device applied to ensure the sensation of treatment and maintain the temperature of moxibustion points. After the 12-week treatment phase, participants will be followed for an additional 36 weeks to monitor the effects. During the study, participants will be evaluated at various times up to 48 weeks. Researchers will measure clinical remission, symptom improvements, disease activity scores, laboratory tests, quality of life questionnaires, anxiety and depression scales, and endoscopic severity. Brain imaging and metabolism levels of TRP-KYN in plasma and intestines will also be assessed. Safety and recurrence rates will be monitored throughout the study.

Researchers are evaluating an upgraded formulation of Elemental 028 Extra, a nutritionally complete amino acid-based feed designed for patients with severe gastrointestinal tract impairments. This case study series focuses on assessing the acceptability, compliance, and gastrointestinal tolerance of the new formulation in both adult and pediatric patients who need an elemental diet due to conditions such as inflammatory bowel disease, short bowel syndrome, malabsorption, allergic diseases, and neurodegenerative disorders. Participants will receive either the powder or liquid versions of the upgraded Elemental 028 Extra feed, which contains increased energy, protein content, and micronutrients to better meet patient needs. The study includes a 1-day baseline period followed by a 28-day intervention period during which the feed is used as a sole source of nutrition. This research is conducted across multiple centers in the UK to meet regulatory requirements for acceptability studies. During the 29-day study, participants will be monitored for gastrointestinal tolerance, acceptability, compliance, and anthropometric measurements at both the start and end of the intervention. Data collection includes assessments of these outcomes to understand how well patients tolerate and adhere to the upgraded feed. The study does not include blinding and follows a protocol designed to ensure patient safety and accurate data on the nutritional supplement's use.

Research is investigating lactose intolerance, a common food intolerance caused by difficulty digesting certain carbohydrates called FODMAPs. Existing diagnosis methods like exclusion diets or hydrogen breath tests have limitations. This study aims to identify breath markers linked to lactose tolerance and intolerance, using lactose intolerance as a model to improve diagnosis and personalize nutrition. It also explores genetic factors and metabolic traits from urine samples to help guide low FODMAP dietary recommendations. Participants will undergo a home lactose tolerance screening using a lactose powder test and saliva collection for genetic analysis. Based on their genetic profiles and symptoms, 120 participants will be divided into three groups. They will consume either a lactose or glucose solution in a randomized, triple-blind setup, swallowing a gas-sensing capsule to monitor intestinal gases. Several biological samples will be collected before and up to six hours after ingestion, including breath, breath condensate, urine, and symptom questionnaires. Participants will complete dietary recalls and provide fecal samples before the intervention. On test day, they will follow a standardized low-FODMAP diet for three days and attend a laboratory visit for sample collection and testing. Breath samples will be collected at nine timepoints post-ingestion, and urine samples will be analyzed for metabolomics. The study measures include diagnostic breath profiles, hydrogen levels, intestinal gas monitoring, and clinical symptoms. A follow-up visit will confirm the capsule's excretion and conclude participation.

Researchers are studying adults with lactase non-persistence (LNP), a genetic condition that causes lactose intolerance due to low lactase enzyme levels. This trial aims to evaluate the effects of drinking lactose-containing versus lactose-free milk on gut bacteria and blood sugar control in people with pre-diabetes who normally consume at least one cup of milk daily. The study is based on findings suggesting milk intake may reduce type 2 diabetes risk in LNP individuals by altering gut microbiota and related metabolites. The study begins with a 2-week milk washout period, after which participants are randomly assigned to drink either lactose-containing (1% or 2%) or lactose-free (1% or 2%) milk for 12 weeks. Milk intake increases in stages: half a cup daily for weeks 1-4, one cup daily for weeks 5-8, then two cups daily for weeks 9-12. After the main study period, participants continue drinking two cups daily for an additional two weeks. Participants will have visits before and after the 12-week milk intervention, with tests including lactose challenge hydrogen breath tests and blood draws for glucose, hemoglobin A1c, and metabolomics. Stool samples and continuous glucose monitoring data will be collected at home. The study will assess changes in gastrointestinal symptoms, gut microbiome characteristics, and various measures of blood sugar control throughout the 12 to 14 weeks of participation.

Researchers are investigating the role of gut microbiota in anorexia nervosa (AN), a serious mental disorder mostly affecting women and characterized by severely restricted food intake and low body weight. This condition often leads to medical complications and psychiatric issues, with current treatments linked to gastrointestinal problems and high relapse rates. The study aims to better understand how gut microbes are affected by standard care treatment and explore the potential of prebiotics as a new approach to improve health and weight restoration in AN patients. The study includes female participants aged 16 to 50 years divided into two groups: those with AN and healthy controls with normal to mild overweight BMI ranges. The AN group will undergo a standard care treatment program involving psychotherapy and nutritional rehabilitation to normalize food intake and promote weight gain. Samples and data are collected at baseline before starting clinical treatment, and again at approximately 6 and 12 weeks during treatment. Healthy controls provide data at one time point only. Participants will have their fecal microbiota composition studied alongside assessments of mental health and gastrointestinal symptoms at multiple time points. Researchers will analyze associations between microbiota diversity, serum biomarkers, diet, and clinical symptoms. The study monitors changes during the treatment period to understand microbiota dynamics and their relation to mental and gastrointestinal health. The study is expected to continue until 2043, aiming to pave the way for personalized prebiotic treatments for AN.

Researchers are studying adults with amyotrophic lateral sclerosis (ALS) to see if drinking an enteral nutrition (EN) formula by mouth before gastrostomy tube (Gtube) placement affects tolerance to feeding via the Gtube. ALS is a progressive disease that often causes swallowing difficulties, leading to weight loss and malnutrition. This study aims to understand if oral intake of EN formula impacts gastrointestinal (GI) symptoms related to feeding intolerance after Gtube placement and how nutritional intake relates to disease progression. The study is a single-arm intervention where all participants receive a plant-based EN formula called Kate Farms 1.4 Standard. It has three stages: a pre-intervention period of one week during which patients maintain their usual diet; Phase I, lasting about two weeks, where participants drink the EN formula to meet their estimated nutritional needs alongside their regular diet; and Phase II, lasting about two weeks post-Gtube placement, where the same formula is fed via the Gtube without changing oral intake. Dietary intake and GI symptoms are collected weekly throughout. Participants will keep a food diary with caregiver support and complete weekly surveys on GI symptoms using the Gastrointestinal Symptom Rating Scale. Researchers will collect demographic and clinical data including disease severity and progression. The main outcome is GI symptoms of feeding intolerance measured over five weeks. Secondary outcomes include dietary intake, body mass index, and ALS functional status. Data will be gathered via phone and email, with safety monitoring for any GI events requiring medical attention during the study period.