Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-26 @ 4:21 PM
Study NCT ID:
NCT04980950
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.', 'timeFrame': 'at baseline and after 7 and 10 days', 'description': 'The composition of gut microbiota (bacteria and fungi) will be assessed from stools. The amounts of bacteria/fungi will be presented using bioinformatics tools and there is no precisely described units (only the total number).'}], 'secondaryOutcomes': [{'measure': 'The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.', 'timeFrame': 'at baseline and after 7 and 10 days', 'description': 'The ratio lactulose/mannitol will be described to assess intestinal permeability. There is no units. Only ratio of two numbers.'}, {'measure': 'The impact of immunonutrition on intestines in gastric and colorectal cancer patients.', 'timeFrame': 'at baseline and after 7 and 10 days', 'description': 'The calprotecin will be assessed. The unit is μg/g.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiota', 'gut barrier integrity', 'enteral immunonutrition', 'gastric cancer', 'colorectal cancer'], 'conditions': ['Gastric Cancer', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Enteral immunomodulating nutrition modifies the gastrointestinal microbiota as well as improves the intestinal barrier integrity in patients with gastric and colorectal cancer in the perioperative period. As a consequence, it contributes to the reduction of the incidence of postoperative complications and diarrhea, which is a side effect of anti-cancer treatment often used preoperatively in this group of cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\>18 y.o.\n* patients with gastric or colorectal cancer\n* patients treated in Department of Surgical Oncology, Medical University of Gdańsk\n* patients' agreement to take part in this study\n\nExclusion Criteria:\n\n* age \\<18 y.o.\n* other types of cancer than gastric/colorectal cancer\n* the presence of inflammatory bowel disease\n* pregnancy"}, 'identificationModule': {'nctId': 'NCT04980950', 'briefTitle': '"The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': '"The Impact of Enteral Immunonutrition on Gut Microbiota, Intestinal Permeability, and Inflammation of Intestines in Colorectal Cancer as Well as Gastric Cancer Patients - a Randomized Trials"', 'orgStudyIdInfo': {'id': 'MUG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gastric cancer patients (immunonutrition)', 'description': 'Experimental gastric cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.', 'interventionNames': ['Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gastric cancer patients (standard nutrition)', 'description': 'These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.', 'interventionNames': ['Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science']}, {'type': 'EXPERIMENTAL', 'label': 'colorectal cancer patients (immunonutrition)', 'description': 'Experimental colorectal cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.', 'interventionNames': ['Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'colorectal cancer patients (standard nutrition)', 'description': 'These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.', 'interventionNames': ['Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science']}], 'interventions': [{'name': 'Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gastric and colorectal cancer patients will receive 1 bottle of immunonutrition or standard nutrition for 10 days. The aims of this study is to assess the effects of these immunonutrition on gut microbiota, intestinal permeability as well as inflammation of intestines in gastric and colorectal cancer patients.', 'armGroupLabels': ['colorectal cancer patients (immunonutrition)', 'colorectal cancer patients (standard nutrition)', 'gastric cancer patients (immunonutrition)', 'gastric cancer patients (standard nutrition)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Karolina Kaźmierczak-Siedlecka (nutritionist, PhD), senior assistant, Department of Surgical Oncology', 'investigatorFullName': 'Karolina Kaźmierczak-Siedlecka', 'investigatorAffiliation': 'Medical University of Gdansk'}}}}