{
    "info": {
        "nct_id": "NCT04784182",
        "official_title": "Synbiotic Supplementation to Reduce Anxiety Symptoms in Female Breast Cancer Survivors and/or Their Female Relatives",
        "inclusion_criteria": "Female breast cancer survivors or female relatives of a breast cancer survivor who:\n\n1. are 50 years of age or older\n2. have completed primary treatment\n3. currently experience clinical anxiety symptoms determined by the 7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)\n4. agree not to change dietary supplements throughout the course of the study\n5. are willing to comply with daily supplement regimen\n6. are able to speak and read English.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 50 Years",
        "exclusion_criteria": "1. use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics\n2. changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks\n3. current use (within 12 weeks) of anxiolytic medications.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Female breast cancer survivors or female relatives of a breast cancer survivor who:",
            "criterions": [
                {
                    "exact_snippets": "Female breast cancer survivors",
                    "criterion": "breast cancer survivor",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "survivor"
                        }
                    ]
                },
                {
                    "exact_snippets": "female relatives of a breast cancer survivor",
                    "criterion": "relative of breast cancer survivor",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. are 50 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "50 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. have completed primary treatment",
            "criterions": [
                {
                    "exact_snippets": "have completed primary treatment",
                    "criterion": "primary treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. currently experience clinical anxiety symptoms determined by the 7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)",
            "criterions": [
                {
                    "exact_snippets": "currently experience clinical anxiety symptoms",
                    "criterion": "clinical anxiety symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)",
                    "criterion": "GAD-7 score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "points"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. agree not to change dietary supplements throughout the course of the study",
            "criterions": [
                {
                    "exact_snippets": "agree not to change dietary supplements",
                    "criterion": "dietary supplements",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. are willing to comply with daily supplement regimen",
            "criterions": [
                {
                    "exact_snippets": "willing to comply with daily supplement regimen",
                    "criterion": "compliance with daily supplement regimen",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. are able to speak and read English.",
            "criterions": [
                {
                    "exact_snippets": "able to speak ... English",
                    "criterion": "English speaking ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to ... read English",
                    "criterion": "English reading ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics",
            "criterions": [
                {
                    "exact_snippets": "use of any of the following drugs within the last 4 weeks ... systemic antibiotics",
                    "criterion": "systemic antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of any of the following drugs within the last 4 weeks ... corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of any of the following drugs within the last 4 weeks ... immunosuppressive agents",
                    "criterion": "immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of any of the following drugs within the last 4 weeks ... commercial probiotics",
                    "criterion": "commercial probiotics",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks",
            "criterions": [
                {
                    "exact_snippets": "changes in treatment for anxiety symptoms",
                    "criterion": "treatment for anxiety symptoms",
                    "requirements": [
                        {
                            "requirement_type": "changes",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "initiation of Cognitive Behavior Therapy (CBT) within the last four weeks",
                    "criterion": "Cognitive Behavior Therapy (CBT)",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. current use (within 12 weeks) of anxiolytic medications.",
            "criterions": [
                {
                    "exact_snippets": "current use (within 12 weeks) of anxiolytic medications",
                    "criterion": "anxiolytic medications",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}