Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:29 AM
Study NCT ID:
NCT07483502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008274', 'term': 'Magnesium'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU time (hours)', 'timeFrame': 'From ICU admission until ICU discharge, up to 30 days', 'description': '1\\. Time in ICU (hours)\n\nThe total time in hours spent in the ICU, calculated from ICU admission following cardiac surgery to ICU discharge to the general cardiology ward'}, {'measure': 'Complications post cardiac surgery', 'timeFrame': 'Number of complications following cardiac surgery, up to 30 days.', 'description': 'The number of Society of Cardio-thoracic Surgery register of complications'}, {'measure': 'Length of hospital stay (days)', 'timeFrame': 'From hospital admission until hospital discharge, up to 30 days', 'description': 'Length of hospital stay from admission to medical discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Surgical outcomes', 'Nutritional prehabilitation', 'Microbiome'], 'conditions': ['Cardiovascular Diseases (CVD)', 'Cardiovascular Surgery']}, 'descriptionModule': {'briefSummary': "More than 7.4 million people in the UK are currently waiting for surgery. Behind that number are real people-patients preparing mentally and physically for procedures ranging from joint replacements to major heart and abdominal operations.\n\nThis research forms part of a broader strategy known as prehabilitation - preparing the body before surgery to improve outcomes afterward. For patients waiting for surgery, it represents a shift from passive waiting to active preparation.\n\nHeart surgery for bypass or valve replacements results in inevitable yet controlled trauma. It increases inflammation, stress hormones and immune system demand. The body then has to repair itself - quickly and efficiently. And here's the surprising part. Inside your gut live trillions of bacteria - called your gut microbiome. These bacteria help regulate inflammation, strengthen your immune system and protect against infection.\n\nThis randomised clinical trial is investigating a fascinating question:\n\nCan improving your gut microbiome through consumption of fibre before surgery help you recover faster, reduce time in ICU, shorten hospital stays, and lower complication rates? The placebo controlled trial will randomise 80 patients following eligibiilty checks to either 5g of prebiotic fibre/300mg of magnesium (WellBiome) OR 5g of maltodextrin for a period of 6-8 weeks prior to surgery. Patient will provide blood, urine and faecal samples at baseline and upon admission for surgery, and two further blood samples at day 3 and 6 post operatively.\n\nFollowing surgery, patient outcomes will be assessed and compared between the experimental group (prebiotic fibre/magnesium) and placebo group (maltodextrin). The investigators are focussing on the time spent in the intensive care unit, complications and overall hospital stay. By documenting and quantifying these the investigators can calculate the costs and any savings between the groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Aged 50-80\n* BMI ≥ 25-40kg/m²\n* Waist circumference \\>94cm (men) and 88cm (women)\n* HbA1c 42-58 mmol/mol (6.0-7.5 old HbA1c units)\n* No known intolerances to oligosaccharides and xylooligosaccharides\n* Be stable dose of cholesterol and blood pressure medication for 3 months\n* Be willing to participate and sign to that effect.\n\nEXCLUSION CRITERIA\n\n* Active cancer\n* Any gastro-intestinal surgery or currently under the care of the GI clinical team for any clinically significant digestive issue (Crohn's, IBS, ulcerative colitis).\n* On or had antibiotic treatment in the last 3 months.\n* Patients who have taken ibuprofen in the last week or any condition that increases the likelihood of regular or sustained use during the intervention.\n* On proton pump inhibitors (Omeprazole, Esomeprazole, Lansoprazole, Rabeprazole, Pantoprazole) within the last one month on long acting non-steroidal anti-inflammatory drugs in the last month or any condition that increases the likelihood of regular use during the intervention.\n* Taking any prebiotic or probiotic supplementation within the last three months\n* Patients who are vegetarians or vegans"}, 'identificationModule': {'nctId': 'NCT07483502', 'briefTitle': 'The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'A Double Blind, Placebo Controlled 6- Week Pre-operative Randomised Clinical Trial of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.', 'orgStudyIdInfo': {'id': '2705622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A matching placebo containing 5g of maltodextrin', 'interventionNames': ['Dietary Supplement: 5g of maltodextrin']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME)', 'interventionNames': ['Dietary Supplement: 5g of prebiotic fibre and 300mg of magnesium (WellBiome)']}], 'interventions': [{'name': '5g of prebiotic fibre and 300mg of magnesium (WellBiome)', 'type': 'DIETARY_SUPPLEMENT', 'description': '5g of prebiotic fibre and 300mg of magnesium (WellBiome)', 'armGroupLabels': ['Experimental']}, {'name': '5g of maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A matched placebo of 5g maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Hull', 'state': 'East Riding Of Yorkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'James Philip Hobkirk, PhD', 'role': 'CONTACT', 'email': 'james.hobkirk3@nhs.net', 'phone': '+44 (0) 7894264660'}, {'name': 'Mahmoud Loubani, MD', 'role': 'CONTACT', 'email': 'mahmoud.loubani@nhs.net'}], 'facility': 'Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'centralContacts': [{'name': 'James Philip Hobkirk, PhD', 'role': 'CONTACT', 'email': 'james.hobkirk3@nhs.net', 'phone': '+44 (0) 7894 264660'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Starting 6 months following publication and ending 5 years after publication.', 'ipdSharing': 'YES', 'description': 'We will share the clinical study report and derived data with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study steering committee.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study steering committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}